Canada Issues Darzalex Recall Due To Complication Risks In Patients
Daratumumab, better known as Darzalex, is an intravenous medication that is produced by Janssen Biotech in order to treat a cancer known as multiple myeloma or Kahler’s disease. Kahler’s disease targets plasma cells in the bone marrow and it can be a debilitating and often fatal disease. Thanks to Darzalex, many people suffering … [Read more...]
Zimmer Biomet Recalled with a Class I Designation Lawsuits
Zimmer Biomet just issued a recall on its Implantable Spinal Fusion Stimulators over the devices' potential to contaminate patients with harmful chemicals. The chemicals may be toxic due to the possibility of harmful chemicals that may be toxic to the body's tissues and organs, according to the U.S. Food and Drug Administration … [Read more...]
Zimmer Persona Tibial Plate Lawsuit
Zimmer replacement knees danger to patients. Currently, nearly 60,000 people have knee replacements annually. There are many potential side effects and dangers can arise anytime someone goes under the knife. Complications can occur from infections and other medical issues. Surgeons must the possible discuss side effects and … [Read more...]
Stockert 3T Surgical Heating-Cooling Device Infection Warning
Warnings for the Stöckert 3T Heater-cooler System. The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have both issued infection warnings for the Stöckert 3T heater-cooler system used to regulate the patient's body temperature during surgery. The agencies have warned specifically about … [Read more...]
Zimmer Persona Trabecular Recall Lawsuit
Zimmer Persona Are Being Recalled. Our firm is investigating potential class action lawsuits on behalf of individuals affected by the … [Read more...]
Zimmer NexGen Revision Surgery Lawsuits
Did you suffer complications following total knee replacement with the … [Read more...]
Zimmer M-L Taper with Kinectiv Technology Recall
Zimmer M-L Taper Are Being Recalled. The U.S. Food and Drug Administration announced on June 8, 2015 that the … [Read more...]
TigerPaw Heart Tissue Damage Risks
The TigerPaw II is an implantable Left Atrial Appendage (LAA) occlusion device meant for use during cardiac surgery. … [Read more...]
Class 1 Recall of Stryker’s Oasys Midline Occiput Plate
Class 1 Recall of Stryker’s Oasys Midline Occiput Plate. The U.S. Food and Drug Administration (FDA) has issued a Class 1 recall – the most serious of all recall classes – for the Stryker Oasys Midline Occiput Plate, a device used in cervical spinal fusion surgery, based on reports of post-operative fracture of a key component of the … [Read more...]
Sierra Pre-Filled Syringes Side Effects May Lead To Bacterial Infection Lawsuits
Sierra Pre-Filled Syringes Side Effects. Sierra Pre-Filled Heparin Syringes caused serious bacterial infections in at least 40 people in Texas and Illinois in December 2007. The patients became infected by flushing their central intravenous catheter with the heparin-filled syringes. Heparin is a blood thinner that prevents the … [Read more...]
Multiple Issues Prompt Class I Recall on HeartWare Device
Class I Recall on HeartWare Device. Our firm is investigating potential lawsuits on behalf of individuals implanted with the HeartWare Ventricular Assist Device (HVAD). In 2015, multiple recalls were issued for the system. Every recall was deemed a Class I, which is the U.S. Food and Drug Administration's (FDA's) most serious … [Read more...]
Medtronic Shunt Recall Side Effects May Lead To Hydrocephalus Lawsuits
Medtronic Shunt Recall Side Effects. The lawyers and attorneys at our firm are offering free consultations to anyone who was injured as a result of defective BioGlide Ventricular Shunt Catheters made by Medtronic Inc. These defective medical devices were subject to a Class I recall in 2009. A Class I recall is the Food & Drug … [Read more...]
Duet TRS Lawsuit Due To Injury
Were you injured by Covidien PLC's Duet TRS single-use cartridge, a device used in medical staplers, during thoracic surgery? In January 2012, Covidien recalled all Duet TRS single use cartidges intended for use in patients’ chest cavities after 3 people died and another 13 were seriously injured by the device. The recall involved … [Read more...]
Avaira Toric Contact Lens Recall Lawyers
Avaira Toric Contact Lens Are Being Recalled. October 12, 2011: CooperVision has stepped up its efforts to recall more than 500,000 Avaira Toric contact lenses under pressure from federal health regulators. The company announced it second recall announcement after reports of torn corneas, blurred vision and other eye problems. The … [Read more...]
Personal Injury Lawsuit: Class I Recall Issued for Puritan Bennett 980 Ventilators
Puritan Bennett 980 Ventilators Injury Lawsuits. Our firm is investigating potential lawsuits on behalf of patients who suffered injuries or death related to the Puritan Bennett 980 Ventilator System (PB980), which was recalled in July 2015 because it may fail to deliver the sufficient amount of oxygen when in the neonatal Volume … [Read more...]
Ankle Evolution Systems Total Ankle Replacement Lawyers
Ankle Evolution Systems, Ankle Replacement Lawyers. Have you suffered complications, including osteolysis or the development of osteolytic lesions, following ankle replacement surgery involving the Ankle Evolution System manufactured by Transystème's and marketed by Biomet? A recall was issued in the U.K. in July 2012 for all lots of … [Read more...]
AMO Healon D OVD Recall Side Effects Lawsuits
AMO Healon D OVD Recall Side Effects. The lawyers and attorneys at our firm are offering free consultations to anyone injured by a contaminated Healon D Ophthalmic Viscosurgical Device (OVD) made by Advanced Medical Optics (AMO). AMO Healon D devices were recalled in December 2008 due to a contamination problem. The action was … [Read more...]
Teva Pharmaceuticals Receive Warning Letter from FDA
FDA Sent Warning Letter To Teva Pharmaceuticals Industries. The U.S. Food and Drug Administration (FDA) has sent a warning letter to Teva Pharmaceutical Industries Ltd on October 14, 2016. The warning letter is associated with an FDA Current Good Manufacturing Practices (CGMP) inspection of Teva's manufacturing facility. The FDA … [Read more...]
Onglyza Serious Side Effects
Litigation Over Kombiglyze XR and Onglyza. Potential Lawsuits Over Onglyza and Kombiglyze XR Drugs. Personal injury attorneys are investigating potential lawsuits over Onglyza and Kombiglyze XR, diabetes medications containing saxagliptin. Drug injury lawyers are reviewing whether or not they can pursue litigation over Kombiglyze … [Read more...]
Thousands of Cook Medical Guidewires Recalled
Contamination Resulted To Recall Of Cook Medical Guidewires. Cook Medical Guidewires has issued a voluntary recall affecting 8,750 units of its Roadrunner UniGlide Hydrophilic Wire Guides because the coating may contain glass particulates. DSM Biomedical B.V., who supplies the coating and launched a recall of its own, notified … [Read more...]
FDA Reports Voluntary Recall of Bupivacaine Hydrochloride Injection
Volunteered Recall forBupivacaine Hydrochloride Injection. On August 5, 2016, Hospira, a Pfizer pharmaceutical company based in Lake Forest Illinois, voluntarily recalled one lot of product as a result of particulate matter found in one vial. The affected product is 0.25 percent Bupivacaine Hydrochloride Injection packaged in 50 … [Read more...]
Class 1 Herpes Test Kits Recalled due to Inaccurate Results
Herpes Test Kits Face Dilemma. Herpes is a highly contagious chronic condition caused by a virus. Many individuals never experience symptoms even though they carry the virus. The HSV1 is oral herpes and symptoms generally include cold sores or blisters. It can be spread through kissing or sharing toothbrushes or eating utensils, … [Read more...]
Class 1 Recall of Boston Scientific Fetch 2 Aspiration Catheter
Complaints About Fetch 2 Aspiration Catheter Recall. The U.S. Food and Drug Administration (FDA) has recalled the Boston Scientific Fetch 2 Aspiration Catheter due to complaints of shaft breakage, reports Nasdaq. This is the most serious type of classification where which indicates there is reasonable probability that "use or … [Read more...]
Fetch 2 Aspiration Catheters Recalled
All Model of Fetch 2 Aspiration Catheters Recall Due to Breakage. Boston Scientific has recalled all models of the Fetch 2 Aspiration Catheters due to reports of shaft breakage that may occur before or during procedures at various points along the device. If breakage occurs while the device is in a patient, pieces of the catheter … [Read more...]
Brainlab Cranial Image-Guided Surgery System Navigation Inaccuracy
Medical technology company Brainlab has recalled the Brainlab Cranial IGS (Image Guided Surgery) System because inaccuracies in the navigation system display could lead to inaccurate medical procedures that could result in life-threatening injuries and death. The Food and Drug Administration (FDA) has categorized this as a Class I … [Read more...]
Digital Thermometers Recalled
Nationwide Recall of Digital Thermometers Initiated by Bestmed, LLC. Bestmed, LLC, a medical device distributor, initiated a nationwide recall of the Digital Temple Thermometer Model No. KD-2201 manufactured by K-Jump Health Co., Ltd. Some of the thermometers display temperatures that are inaccurate and lower than actual body … [Read more...]
OmniPod Insulin Device May Malfunction Insulet Warns
Insulet Corporation Issued Field Safety Notification to Omnipod Insulin Device. Insulet Corporation has issued a Field Safety Notification involving the OmniPod (Pod) Insulin Management System. The voluntary Nov. 2 alert, which was specific to 15 lots of the Pod, stated that the needle mechanism may fail to deploy or be slow to … [Read more...]
Software Problem with Hamilton-G5 Ventilator Results in Recall
Hamilton Medical Recalled Hamilton-G5 Ventilator. Recalled Software Problem of Hamilton Ventilator. Hamilton Medical has recalled 1,128 Hamilton-G5 ventilators because a software problem can unintentionally suppress ventilation alarms. The recall, posted on November 4, is the second Class 1 recall of Hamilton Medical ventilators … [Read more...]
Cook Medical Recalls 38,985 Beacon Tip Catheters
The tip could enter the patient’s bloodstream, causing serious injury or even death. Device maker Cook Medical has recalled nearly 39,000 Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, and Slip-Cath Beacon Tip Catheters because of reports that the catheter tip may split or separate from the … [Read more...]
Congress Would Weaken Testing and Regulation of Medical Devices
Approval process usually requires one clinical trial to demonstrate safety and effectiveness. In an op-ed piece this week in the New York Times, two prominent cardiologists warn that legislation currently before Congress could dangerously weaken the standards the Food and Drug Administration (FDA) uses to determine the safety and … [Read more...]
Class I Recall Issued for Maquet’s FLOW-i Anesthesia System
FLOW-i is used in hospitals to administer anesthesia and breathing support to patients. Maquet's FLOW-i Anesthesia Systems have an issue that stops the ventilator from providing adequate breathing support, the U.S. Food and Drug Administration (FDA) warned. The FLOW-i is used in hospitals to administer anesthesia and breathing … [Read more...]
Baxter Says Peripheral Vascular Patch Recall was Due to Packaging
Peripheral Vascular Patch Recalls. Baxter International, Inc. says new packaging is to blame for the Class I recall of its peripheral vascular patches, Qmed reports. Class I recalls are the most serious type of recall; they are reserved for recalls in which exposure to the drug can reasonably lead to serious health consequences or … [Read more...]
Baxter Recalls Vascu-Guard Peripheral Vascular Patch
Vascu-Guard Peripheral Vascular Patch. According to a safety alert posted on the U.S. Food and Drug Administration's (FDA) website on June 3, 2015, Baxter International, Inc. is recalling some of its Vascu-Guard Peripheral Vascular Patches. The voluntary recall is being issued because customers complained that it is difficult to … [Read more...]
Wrong Internal Component Leads to Class I Recall of ConMed Stat2 Flow Controller
Recall Issued For ConMed Stat2 Flow Controller The U.S. Food and Drug Administration (FDA) has announced that ICU Medical, Inc. issued a recall for its ConMed Stat2 Flow Controller. The FDA deemed the recall a Class I, the agency’s most serious recall designation. ICU Medical Inc. is recalling the Stat2 Flow Controller over an … [Read more...]
DePuy Synthes Recall is Labeled as Class I, Risk of Airway Obstruction
FDA considers this most serious recall status. DePuy’s recall of the Synthes Craniomaxillofacial (CMF) Distraction System (AB Distractor Bodies and BC Distractor Bodies) has been deemed Class I by the U.S. Food and Drug Administration (FDA); this is the most serious recall status, and indicates that the recalled device can cause … [Read more...]
Testing Conducted on Blood Pressure Drugs
Federal regulators announced that extensive research on blood pressure medications will be conducted following thousands of complaints. Federal regulators announced that extensive research on blood pressure medications will be conducted following thousands of complaints made by physicians and patients. Some 40 million … [Read more...]
FDA Moves HeartWare Ventricular Assist System Recall into Most Serious Category
Agency believes “will cause serious adverse health consequences or death”. The U.S. Food and Drug Administration (FDA) this week placed its highest-risk label on a recall of HeartWare International's circulatory support system because a failed locking mechanism could leave the device without power. The FDA bumped the recall to … [Read more...]
FDA Plan for more Efficient Medical Device Recalls, Removal and Reporting Moves Forward
Efficient Recalls For Defective Medical Device. The U.S. Food and Drug Administration (FDA) is moving forward with their plan to make the reporting of medical device removals and corrections easier, Regulatory Focus reports. In June 2013, the agency said that they wanted to make submissions of “806 reports” easier; these filings are … [Read more...]
Stryker Oasys Spine Device Recall One in a Stream of Issues
Device Maker Stream of Issues. Undergoing spinal surgery is a frightening and worrisome prospect for patients, and patients agree to these typically complex procedures believing the medical device products being used in their surgeries—and in their bodies—are safe and effective. In the case of the Stryker Orthopedics’ Oasys … [Read more...]
FDA Deems the Recall of EZ Breathe Atomizer as a Class 1
Agency believes using one of these products is likely to result in serious injuries or death. The U.S. Food and Drug Administration (FDA) has deemed a recall initiated for Nephron Pharmaceuticals Corp.’s EZ Breathe Atomizer to be a Class 1. The Class 1 designation for recalled pharmaceuticals and medical devices is the FDA’s most … [Read more...]
Class I Status Given to CooperVision Avaira Sphere Contact Lens Recall
CooperVision Avaira Sphere Contact Lens Have Problems. Like the previous Avaira Toric contact lens recall announced in August, the U.S. Food & Drug Administration (FDA) has decided to classify CooperVision's Avaira Sphere contact lens recall Class I, its most serious type of recall action. Class I recalls involve situations in … [Read more...]
6 Million Avaira Sphere Contact Lenses Added to CooperVision Recall
CooperVision Recall Avaira Sphere Contact Lenses. A month after it came under fire for its handling of the Avaira Toric contact lens recall, CooperVision Inc. is expanding the recall to include another Avaira brand. The expansion involves 6 million Avaira Sphere contact lens, 4.9 million of which were shipped to … [Read more...]
CooperVision Contact Lens Recall Given Class 1 Status
around 600,000 lenses were involved in the Avaira Toric contact lens recall The Food & Drug Administration (FDA) has assigned its most serious recall classification - Class 1 - the recent CooperVision Avaira Toric contact lens recall. It also seems that the U.S. CooperVision contact lens recall involves more lenses than first … [Read more...]
CooperVision Widens Contact Lens Recall Notification
Avaira Toric contact lens recall on August 19 Yesterday, CooperVision Inc. reannounced its Avaira Toric contact lens recall, following criticism that its initial notification had downplayed the serious risks posed by the defective lenses. In a press release issued yesterday, CooperVision also acknowledge that some users of the … [Read more...]
J&J Warned Over Marketing of Two Devices
Illegally marketing two products. In the newest string of debacles surrounding drug giant Johnson & Johnson (J&J), it just received a warning letter from the U.S. Food and Drug Administration (FDA) stating it is illegally marketing two products, wrote Daily Finance. We’ve previously written that J&J is expecting more … [Read more...]
St. Jude 6 French Engage Introducer Devices Class I Recall
French Engage Introducer Devices. St. Jude Medical has issued an urgent recall for 6 French Engage Introducer devices. The US Food & Drug Administration (FDA) has deemed this a Class I recall, its most serious recall action. The Engage Introducer is used to implant catheters and electrodes into blood vessels during surgery and … [Read more...]
Edwards Lifesciences Warned on Heart Devices
Warned on Heart Devices. In a letter released yesterday, the U.S. Food and Drug Administration (FDA) said that Edwards Lifesciences Corporation failed to appropriately report six complaints concerning serious problems in patients treated with Edwards’ heart devices, said Reuters. The FDA said, added Reuters, that Edwards … [Read more...]
Mentor ObTape Lawsuits Proceeding
Mentor ObTape Lawsuits. Legal action on behalf of women injured by the Mentor ObTape Vaginal Sling is proceeding with four cases scheduled for trial in California. In an order dated March 30, 2010, the California Superior Court denied Mentor Corporation’s motions to dismiss in four of the lawsuits, refusing to dismiss two of the … [Read more...]
FDA Deems Abiomed Device Recall Class I
A Class I recall has been issued for Abiomed, Inc.’s AB5000 Circulatory Support System. A Class I recall has been issued for Abiomed, Inc.’s AB5000 Circulatory Support System. The AB5000 Circulatory Support System supplies power to disposable blood pumps used to support the left and/or right sides of the heart. According to the … [Read more...]
Class I Recall for Gyrus ACMI Ear Device
Gyrus ACMI Ear Device Are Being Recalled. The recalled device is intended to be implanted for ventilation or drainage of the middle ear. A Class I recall has been issued by Gyrus ACMI, Inc. for Micron Bobbin Vent Tube T, 1.27 mm. The recalled device is intended to be implanted for ventilation or drainage of the middle ear. Class I … [Read more...]
Recall Issued for Becton Dickinson IV Devices
Recalled by Becton Dickinson & Co. for a potentially lethal defect. Millions of BD Q-Syte Luer Access Devices and BD Nexiva Closed IV Catheter Systems have been recalled by Becton Dickinson & Co. for a potentially lethal defect.The approximately 2.8 million BD Q-Syte and 2.9 million BD Nexiva units containing 5 million BD … [Read more...]
System II Surgical Navigation Systems Recall
Surgical Navigation Systems Recall. Stryker Corporation’s Instruments division has initiated a worldwide, Class 1 recall of 23 Operating Room System II Surgical Navigation Systems. A Class 1 recall is the U.S. Food & Drug Administration's (FDA) most serious type of recall, and involves situations in which there is a reasonable … [Read more...]
ViperSheath Sheath Introducer Could Break
Fracturing ViperSheath Sheath Introducer. Cardiovascular Systems Inc (CSI) has initiated a recall of all lots of the ViperSheath Sheath Introducer on behalf of Thomas Medical. According to the recall notice, Thomas Medical has received reports of fracturing or stretching occurring when the ViperSheath Sheath Introducer is in … [Read more...]
Synthes USA Issues Class I Recall for Vertebrae Replacement Implants
Synthes USA Vertebrae Replacement Implants Have Issues. Synthes USA is recalling all lots of the Ti Synex II Vertebral Body Replacement device. The U.S. Food & Drug Administration (FDA) has deemed the Synthes USA Ti Synex II Vertebral Body Replacement recall a Class I recall. The Ti Synex II Vertebral Body Replacement is used in … [Read more...]
Edwards Lifesciences Recalls Aortic Catheters
Aortic Catheters Having Problems Edwards Lifesciences Corporation has issued a recall of CardioVations EndoClamp Aortic Catheter. The Food & Drug Administration (FDA) has deemed this a Class I recall, its most serious type of recall. The CardioVations EndoClamp Aortic Catheter locks off the aorta, monitors aortic pressure, … [Read more...]
Centurion Premie and Meconium Packs Recalled
Centurion Premie and Meconium Medical Products Recalled. Centurion Medical Products Premie Pack and Meconium Pack Pediatric Tracheal Tubes have been recalled, the U.S. Food and Drug Administration (FDA) just announced. The tubes were manufactured with an internal diameter smaller than that indicated on label. The recall has been … [Read more...]
FDA Investigating Faulty Power Cords on Medical Devices
Faulty Power Cords on Medical Devices. Medical device manufacturers Hospira Inc. and Abbott Nutrition have submitted 122 reports of sparking, charring, and fires from faulty power cords used with their devices to the Food & Drug Administration (FDA). Those reports have prompted the agency to launch an investigation to determine … [Read more...]
Unomedical Recalls Manual Pulmonary Resuscitators
Manual Pulmonary Resuscitators. Certain units of the single-patient use Manual Pulmonary Resuscitator (MPR) have been recalled by Unomedical Inc. This recall is being conducted because of a potential malfunction of the MPR, which may impair the ability of the device to generate the positive pressure necessary to function properly. … [Read more...]
System Needed to Track Recalled Medical Devices
Even though medical device recalls have increased in recent years, the Food & Drug Administration (FDA) has not devised an effective process for notifying the public about dangerous devices. According to an Associated Press report, lack of such a process has put patients in danger. In 2008, 2,500 defective medical devices … [Read more...]
Penumbra Recalls Neuron Catheter
Original Version of Penumbra. Penumbra is initiating a voluntary Field Removal of the original version of its Neuron 6F 070 Delivery Catheter, the U.S. Food and Drug Administration (FDA) just announced. Penumbra has received feedback from some users that these recalled catheters could kink or ovalize in certain anatomical … [Read more...]
Covidien Issues Class I Recall for Pedi-Cap End-Tidal CO2 Detectors
Pedi-Cap End-Tidal CO2 Detectors Are Being Recalled. A Class I recall has been issued for Pedi-Cap End-Tidal CO2 Detectors (Pedi-Cap and Pedi-Cap 6). Class I recalls are the Food & Drug Administration's most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause … [Read more...]
Penumbra 5F Select Catheters Named in Class I Recall
Class I Recall for Select Catheters Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious injury or death. The Neuron 5F Select Catheter is used to remove blood clots or foreign objects from blood vessels. The device was … [Read more...]
Hospira Recalls Devices Over Defective Power Cords
Hospira Equipment Defective Power Cords. Hospira Inc. is issuing an urgent recall for some medical delivery equipment because the devices include defective AC power cords manufactured by Electri-Cord Manufacturing Corporation. … [Read more...]
Powersail Coronary Dilatation Catheters Class I Recall
Powersail Coronary Dilatation Catheters. A Class I recall has been issued for four lots of Powersail Coronary Dilatation Catheters made by Abbott Vascular. A Class I recall is the Food & Drug Administration's (FDA) most serious type of recall, and is issued when a medical device could predictably cause serious health problems … [Read more...]
Respironics’ Recall of BiPAP Ventilator Systems
Most serious type of recall A recall of BiPAP Focus Non-Invasive Ventilator Systems issued by Respironics California last September has been deemed a Class I recall by the Food & Drug Administration (FDA). Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that … [Read more...]
Synthes Inc. Indicted Over Norian XR Bone Cement Tests
Medical devices investigation. Medical device maker Synthes Inc. and its Norian subsidiary have been indicted on charges of illegally testing Norian XR bone cement on humans. According to Bloomberg.com, those trials - some of which were conducted at VA hospitals - allegedly resulted in the deaths of three patients from severe low … [Read more...]
Respironics Issues Class I Recall of SmartMonitor 2 Infant Apnea Monitors
SmartMonitor 2 Infant Apnea Monitors Under Probe. Respironics, Inc. of Murrysville, PA is voluntarily recalling more than 4,900 defective infant apnea monitors. According to the company's notice, the recall of its SmartMonitor 2 infant apnea monitors is being conducted due to the possibility of an audible alarm failure, which … [Read more...]
Baxter Warned on Tisseel Sealant Promo
Baxter's Tisseel Sealant Promo Gets Warning. Baxter International has received a warning letter from the U.S. Food and Drug Administration over how it promoted its Tisseel surgical sealant, reports Reuters. The letter states that Baxter’s marketing of Tisseel were misleading, citing a brochure and other sales materials, said … [Read more...]
Mentor ObTape Fast-Track Approval Questioned
Mentor ObTape's Fast-track Approval Questionable, says Report. A new report is raising questions about the fast-track approval of the Mentor ObTape. According to The New York Times, the device has become the subject of numerous lawsuits since Mentor Corporation removed it from the market in 2006. The Mentor ObTape, used to treat … [Read more...]
Accu-Check Spirit Insulin Pumps Recalled
Spirit Insulin Pumps Has Problems, says report. Accu-Check Spirit insulin pumps are being recalled by Disetronic Medical Systems Inc., a unit of the Roche Group, because of a potential defect in the “up” and/or “down” buttons of some devices. According to the recall notice, if the buttons do not function, users may not be able to … [Read more...]
Intra-Aortic Balloon Pump Catheters Recalled
Intra-Aortic Balloon Pump Catheters. A recall of Intra-Aortic Balloon Pump Catheters issued by Arrow International in February has been deemed a Class I recall by the Food & Drug Administration (FDA). A Class I recall is the FDA's most serious recall action, and indicates that a device poses a reasonable probability of serious … [Read more...]
FDA Issues Injectable Pen Warning
FDA Issued an Alert About Single-Patient Insulin Pens. The U.S.Food and Drug Administration (FDA) just issued an alert to health care professionals reminding them that single-patient insulin pens and insulin cartridges should not be used to administer medication to multiple patients because of the potential risk of transmitting … [Read more...]
Calaxo Bone Screw Causing Painful Complications for ACL Surgery Patients
Calaxo Bone Screw Causing Painful Complications. A simple medical device called the Calaxo Bone Screw has been causing a great deal of pain and suffering for those who have undergone Anterior Cruciate Ligament (ACL) reconstructive surgery. The Calaxo Bone Screw was recalled in August 2007 due to reports of serious complications. Some … [Read more...]
Covidien Recalls Pediatric Tracheostomy Tubes
Covidien Tracheostomy Tubes Have Problems. Covidien Inc. is recalling several lots of Shiley 3.0PED Cuffless Pediatric Tracheostomy Tubes because practitioners have reported difficulty inserting two of the device's components during procedures. The action has been deemed a Class I recall, the Food & Drug Administration's (FDA) … [Read more...]
Stryker Recalls Crania Implant Kits
Cranial Implant Kits recalled over sterility issues. Custom-made Cranial Implant Kits made by Stryker Corp. have been recalled over sterility issues. accurate The Stryker cranial implant kit recall has been deemed a Class I recall by the FDA. Class I recalls are the most serious type of recall and involve situations in which there … [Read more...]
Sun Med Laryngoscope Blades Named in Class I Recall
Laryngoscope blades has problems. A Class I recall has been issued for laryngoscope blades distributed by Sun Med of Largo, Florida. The Food & Drug Administration (FDA) issues Class I recalls when there is a reasonable probability that the use of a device will cause adverse health consequences or death. The Sun Med … [Read more...]
Unapproved Medical Devices Subject to Class I Recall
There is a reasonable probability that the use of a device will cause adverse health consequences or death. Federal regulators have announced a Class I recall of two unapproved unapproved medical devices. The recall involves Vibrational Integrated Bio-photonic Energizer (VIBE device) sold by VIBE Technologies of Greeley, CO and the … [Read more...]
Integra NeuroSciences Recalls Gravity Compensating Accessory
Gravity Compensating Accessory recall is serious type. Integra NeuroSciences is recalling Gravity Compensating Accessory used with brain shunting systems. According to the Food & Drug Administration (FDA) notice, the Gravity Compensating Accessory recall is a Class I recall - the agency's most serious type. A shunt is a tube … [Read more...]
Terumo CVS Recalls Tenderflow Pediatric Arterial Cannulae
Difficulty retracting the introducer from the cannula. Terumo Cardiovascular Systems is issuing an urgent recall for its Tenderflow Pediatric Arterial Cannulae. According to the Food & Drug Administration (FDA), the recall was issued after Terumo received five reports of difficulty retracting the introducer from the … [Read more...]
Animas Recalls Battery Caps on Insulin Pumps
Defective battery caps could cause the pumps to stop administering insulin. A Class I recall has been issued for battery caps included with some varieties of Animas insulin pumps. According to Animas Corp, the defective battery caps could cause the pumps to stop administering insulin, putting patients at risk of hyperglycemia or … [Read more...]
FDA Recalls VIBE Machine for Unproven Claims
VIBE Machine has problems. Federal regulators have issued another Class I recall for an unapproved medical device. This time, the Food & Drug Administration (FDA) has recalled the Vibrational Integrated Bio-photonic Energizer (VIBE) Machine Multi-Frequency Electromagnetic Field Generator sold by VIBE Technologies of Colorado. … [Read more...]
Rushed Medical Device Approvals Endangering Patients
Rushed Medical Device Approval. Thousands of medical devices are approved every year in the U.S. without proof of their effectiveness. The Food & Drug Administration (FDA) defends this process - known as 501(k) approvals - by claiming that it promotes innovation. But a recent article in The New York Times raises serious concerns … [Read more...]
Thoratec Recalls Heart Pumps After Deaths
Blood pump with the System Controller may result in damage that could interrupt pump function. Five deaths have prompted the Thoratec Company to recall its HeartMate II implantable heart pumps. According to the Food & Drug Administration (FDA), wear and tear of the percutaneous lead connecting the HeartMate II Left Ventricular … [Read more...]
Johnson & Johnson Recalls Lonsys Pain Drug Device
Mounting concerns about Johnson & Johnson’s ability to develop profitable new products. Johnson & Johnson just issued a recall in Europe for its Lonsys pain treatment device, which is used in hospitals. This recent recall is only serving to add to mounting concerns about Johnson & Johnson’s ability to develop profitable … [Read more...]
False Claims Prompt Recall of Magnetic Resonance Device
Magnetic Resonance Device Subject Of An Investigation. A magnetic resonance device made by Nebion, LLC of California is subject to a Class I recall. According to the Food & Drug Administration (FDA), the Nebion HLX-8 Magnetic Resonance Device was not approved by the agency, lacked safety and effectiveness data, and was not … [Read more...]
Levitronix Recalls CentriMag Extracorporeal Blood Pumping System
Levitronix Defective Medical Devices Lawsuit. Levitronix has issued a Class I recall for its CentriMag Extracorporeal Blood Pumping System and Primary & Backup Consoles. The defective medical device was distributed from the manufacturer in Switzerland to distributors world-wide including the United States. The company … [Read more...]
Sage Products Recalls Medical Device for Bacterial Contamination
Medical Device Could be Contaminated With Burkholderia cepacia. Sage Products Inc. has issued a recall of some lots of 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation because it could be contaminated with the bacteria Burkholderia cepacia (B. cepacia). Customers who have these products should stop usage, sale … [Read more...]
Icy Hot Heat Therapy Patch Recall Elicits FDA Warning Letter
Company warned for failing to notify the agency of labeling cautions added to the product after the company received more than 168 injury complaints. The maker of Icy Hot Heat Therapy patches has been issued a warning letter from the Food & Drug Administration (FDA) for failing to notify the agency of labeling cautions added to … [Read more...]
Heparin-Coated Hydraglide Catheters Recalled
Recalled catheters are used for autotransfusion during cardiopulmonary bypass surgery. Another medical device maker is recalling a heparin-coated product amid fears that the drug could be contaminated. Earlier today, preventive. The recalled catheters are used for autotransfusion during cardiopulmonary bypass surgery. Tainted … [Read more...]
China to Crack Down on Medical Device Makers
China Warns to Revoke The Licenses of Medical Device Makers. China will revoke the licenses of those manufacturers producing unqualified medical devices that cause disastrous results, according to a draft on the administration of medical device recalls. The Chinese government will assign compulsory recalls and levy penalties of … [Read more...]
Baxter Heparin Vials Recalled due to ‘Allergy-Type’ Reactions
Baxter Heparin Vials makes patients worried. Heparin Sodium Injection Vials manufactured by Baxter HealthCare have been recalled because of a marked increase in adverse reactions related to the Heparin. Baxter has received 100 reports of allergy-type reactions linked to the Heparin, and one death at a Florida hospital could be … [Read more...]
B.C. Ear Bank Lawsuit Defendants Granted Chance to Appeal
B.C. Ear Bank Distributed Defective Tissue And Bone. The B.C. Ear Bank, a Canadian ear bank that was forced to close in 2002 after it was learned that it may have distributed defective tissue and bone that had not been tested for HIV, the virus that causes AIDS, and other diseases, will be allowed to appeal a decision in a British … [Read more...]
Alaris Pump Modules Recalled by Cardinal Health Following Death Reports
Defect in The Alaris Pump Modules that Could Lead to Over-Infusion. Alaris Pump Modules manufactured by Cardinal Health where recalled this week due to a defect in the pumps that could lead to over-infusion. The company became aware of the defective medical devices following a review of customer complaints and service data. Cardinal … [Read more...]
Counter TS Test Strip Recall Issued After Bayer Diabetes Care Reports Manufacturing Issue
Bayer Diabetes Care Voluntary Recall of Counter TS Test Strip. Bayer Diabetes Care has initiated a voluntary market recall of test strips—or sensors—that are used exclusively with the Contour TS Blood Glucose Meter. In the course of its routine quality control monitoring processes the Bayer Diabetes Care identified a manufacturing … [Read more...]
Thoratec Recall Issued for Defective IVAD Drivers
Worldwide Recall Of IVAD Drivers. Thoratec Corporation has issued a worldwide recall of all of its Implantable Ventricular Assist Device (IVAD) Drivers because the “Instructions for Use” included with the IVAD Drivers included incorrect information. As a result, the recalled Thoratec IVAD Drivers could be implanted incorrectly. The … [Read more...]
Boston scientific recalls catheters
Enables delivery of medical devices for the heart. Boston Scientific Corp. said it is voluntarily recalling 51 catheters in the United States. The products that are affected are certain lots of the Mach 1 Guide Catheters. A catheter is a tube that enables delivery of medical devices to the heart to treat coronary artery … [Read more...]
The Mentholatum Company Issues a Nationwide Voluntary Recall of WellPatch Cough & Cold Soothing Vapor Pads in the U.S.
Recall due to potential serious adverse health effects. The Mentholatum Company announced today it is conducting a nationwide voluntary recall of WellPatch Cough & Cold Soothing Vapor Pads due to potential serious adverse health effects that could result if the product is ingested by a child removing the patch and chewing on … [Read more...]
Berlex Voluntarily Recalls Ultravist(R) Injection 370 mgI/mL
Berlex Voluntarily Recall Its X-ray Contrast Agent Ultravist Injection. Berlex, Inc., a US affiliate of Schering AG, Germany, is voluntarily recalling all lots of its X-ray contrast agent Ultravist Injection 370 mgI/mL (iopromide injection), as part of a worldwide recall, due to the potential that particulate matter in conjunction … [Read more...]
Disetronic Medical Systems Inc Announces a Recall
Disetronic Medical Systems Nationwide Recall. Disetronic Medical Systems Inc. (Disetronic) of Fishers, IN announced today a voluntary nationwide recall of the Disetronic D-TRONplus Power Packs, that power the D-TRONplus Insulin Pump. There is the real potential that the power pack could shut down the D-TRONplus Insulin Pump … [Read more...]
Respironics Recalls PLV Continuum Ventilators
Recalled all units of one of its ventilator models because the machine could stop without warning. Respironics Inc., a maker of respiratory products, said Friday it voluntarily recalled all units of one of its PLV Continuum ventilators because the machine could stop without warning. The company said it was recalling all 269 of its … [Read more...]
