St. Jude Medical Amplatzer Recall Lawsuits
Amplatzer TorqVue FX Delivery System Recall Lawsuits. Parker Waichman LLP is currently investigating lawsuits on behalf of individuals who were injured due to the Amplatzer TorqVue FX Delivery System, which is used to help treat people with a hole in the heart. Reports suggest that this device, which is manufactured by … [Read more...] about St. Jude Medical Amplatzer Recall Lawsuits
St. Jude Defibrillator Side Effects
St. Jude Defibrillator Side Effects. In November 2007, reports emerged that St. Jude Riata Defibrillator Lead wires had perforated the hearts of some patients. That month, the medical journal Pace published a report detailing four instances in which the St. Jude Riata Defibrillator Lead wire detached and perforated the heart … [Read more...] about St. Jude Defibrillator Side Effects
St. Jude Continued to Sell Old ICDs
Premature Battery Failure Found In Heart Devices. St. Jude says it continued to ship old versions of its heart devices after the company implemented a design change that prevents premature battery failure. Ultimately, early battery depletion issue has prompted the devices, implantable cardioverter defibrillators (ICDs) and cardiac … [Read more...] about St. Jude Continued to Sell Old ICDs
FDA Places Highest-Risk Class I Label on St. Jude ICD CRT-D Recall
Risks of Using Implantable Cardioverter Defibrillators. The U.S. Food and Drug Administration (FDA) has placed its most serious Class I label on a St. Jude Medical recall affecting hundreds of thousands of pacemakers prone to premature battery depletion. The St. Jude ICD CRT-D devices in question are implantable cardioverter … [Read more...] about FDA Places Highest-Risk Class I Label on St. Jude ICD CRT-D Recall
Highest-Risk Class I Label on St. Jude ICD CRT-D Recall
Class I Label On ICD CRT-D Recall. The U.S. Food and Drug Administration (FDA) has placed its most serious Class I label on a St. Jude Medical recall affecting hundreds of thousands of pacemakers prone to premature battery depletion. The devices in question are implantable cardioverter defibrillators (ICDs) and cardiac … [Read more...] about Highest-Risk Class I Label on St. Jude ICD CRT-D Recall
St. Jude ICD Recall Is Deemed a Class I by Federal Regulators
St. Jude recently reported two patient deaths tied to early depletion of lithium batteries in St. Jude Medical Implantable Cardioverter Defibrillators (ICD) and Cardiac Resynchronization Therapy Defibrillators (CRT-D). The U.S. Food and Drug Administration (FDA) and St. Jude issued an alert to patients, caregivers, and physicians, … [Read more...] about St. Jude ICD Recall Is Deemed a Class I by Federal Regulators
St. Jude Medical Pacemaker Linked to 2 Deaths
2 Deaths Blamed On Medical Pacemaker - FDA. A battery defect with some St. Jude Medical implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) may cause the pacemaker devices to stop working sooner than expected. These heart devices are implanted in the upper chest area and … [Read more...] about St. Jude Medical Pacemaker Linked to 2 Deaths
St. Jude Medical Pacemaker Linked to 2 Deaths
CRT-D May Cause The Pacemaker To Stop Working. A battery defect with some St. Jude Medical implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) may cause the pacemaker devices to stop working sooner than expected. These heart devices are implanted in the upper chest area and … [Read more...] about St. Jude Medical Pacemaker Linked to 2 Deaths
Premature Battery Depletion of Defibrillator Caused Two Deaths
On October 11, 2016, the U.S. Food and Drug Administration (FDA) issued a safety warning for premature battery depletion of the St. Jude Medical Implanted Defibrillator. The St. Jude products in question were manufactured before May 2015 and are ICD and CRT-D models. A medical advisory has been released by St. Jude Medical. The … [Read more...] about Premature Battery Depletion of Defibrillator Caused Two Deaths
Investigation of St. Jude Medical Devices Now Includes FDA
The U.S. Food and Drug Administration (FDA) has now joined the investigation into security claims that devices made by St. Jude Medical can be hacked remotely. These claims are still being defended by St. Jude. Muddy Waters Capital, an investment group, says that St. Jude Medical pacemakers and defibrillators are particularly … [Read more...] about Investigation of St. Jude Medical Devices Now Includes FDA
FDA: Serious Erosion Events Tied to St. Jude Amplatzer Atrial Septal Occluder (ASO)
Tissue Surrounding Amplatzer Atrial Septal Occluder Can Erode. The St. Jude Amplatzer Atrial Septal Occluder (ASO) has been associated with rare, but serious, erosion events, according to the U.S. Food and Drug Administration (FDA). The ASO is a cardiac implant device used in both pediatric and adult patients to treat an abnormal … [Read more...] about FDA: Serious Erosion Events Tied to St. Jude Amplatzer Atrial Septal Occluder (ASO)
Stronger St. Jude Durata Warning
St. Jude Durata Stronger Warning From FDA.Food & Drug Administration threatened to either impose a fine or take other actions against St. Jude Medical for neglecting to respond to the federal regulator’s concerns about the heart device, said The New York Times. In 2011, St. Jude issued a Class I recall on its Riata and … [Read more...] about Stronger St. Jude Durata Warning
St. Jude Medical’s reputation in the balance amid Riata, Durata scandals
St. Jude Medical Riata And Durata Scandals. What is the name of the medical device blacked out in a recent federal report made public by St. Jude Medical, one of the leading companies in the industry. Speculation abounds, according to a New York Times report, on which product is redacted from a recent federal report on the medical … [Read more...] about St. Jude Medical’s reputation in the balance amid Riata, Durata scandals
Little Girl with St. Jude Riata Defibrillator Lead Faces Uncertainty
The dangers posed by these defective St. Jude Riata Defibrillator. The dilemma faced by people who rely on the St. Jude Riata or Riata ST implanted cardiac defibrillator leads is not just limited to older patients. In a New York Times report this week, the dangers posed by these defective and recalled defibrillator leads … [Read more...] about Little Girl with St. Jude Riata Defibrillator Lead Faces Uncertainty
Doctors Criticize St. Jude’s Heavy-Handed Management
St. Jude's vigorous defense of its trouble Riata line of internal defibrillator leads may not be working out as well as it had hoped. According to a report in The New York Times, some doctors have tired of St. Jude's tactics, and would rather the device maker put more effort toward helping patients with defective Riata and Riata ST. … [Read more...] about Doctors Criticize St. Jude’s Heavy-Handed Management
St. Jude Recalls Riata Leads
St. Jude Riata Lead Recall Stop Sales. A year after stopping sales of its Riata family of defibrillator leads, St. Jude Medical Inc. is officially recalling the defective devices. The ST. Jude Riata defibrillator lead recall has been deemed Class I by the U.S. Food & Drug Administration (FDA), meaning the leads pose a … [Read more...] about St. Jude Recalls Riata Leads
St. Jude Served with FDA Warning Letter
Faulty manufacturing practices blamed on St. Jude. The U.S. Food and Drug Administration (FDA) sent a warning letter this week to St. Jude Medical Inc. because of faulty manufacturing practices at its catheter manufacturing plant in Minnetonka, Minnesota. The letter was released in a regulatory filing with the U.S. Securities and … [Read more...] about St. Jude Served with FDA Warning Letter
Medtronic Sprint Fidelis, St. Jude Riata Defibrillator Endanger Patients
Defective devices lead to additional cardiac procedures or complications and even death People with a Medtronic or St. Jude … [Read more...] about Medtronic Sprint Fidelis, St. Jude Riata Defibrillator Endanger Patients
St. Jude Riata Defibrillator Lead Wires Perforating Patients’ Hearts
St. Jude Riata Defibrillator Lead Wires Has Problems. St. Jude Riata Defibrillator Lead wires have been detaching from patients’ hearts and perforating the heart wall, according to reports published in a major medical journal. While such malfunctions can happen with any defibrillator lead, evidence is emerging that such detachment … [Read more...] about St. Jude Riata Defibrillator Lead Wires Perforating Patients’ Hearts
