Boston Scientific Angiographic Catheters Under Class I Recall by FDA
WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) characterized Boston Scientific’s Angiographic Catheter Imager II 5F (Imager) as a Class I recall initiative. The FDA’s Class I designation means that the FDA believes that the defect in Boston Scientifics’ Imager could kill or cause a serious injury to a patient. In its … [Read more...]
Paclitaxel Vascular Devices
Boston Scientific and Medtronic Reject Recent Study Showing Dangers of Their Paclitaxel Vascular Devices A recently published study by the Journal of the American Heart Association (JAHA) concludes that patients with certain drug-eluting vascular stents manufactured by Boston Scientific Corporation and Medtronic are at an … [Read more...]
Venture Catheters Recalled
Certain versions of the Venture Catheters made by Vascular Solutions are being recalled because of some excess material that may split or separate during a procedure potentially harming the patient. Excess material at the tip of the catheter may separate and could enter the patient's bloodstream. This may result in a serious adverse … [Read more...]
West Virginia as Venue for Transvaginal Mesh Lawsuits
Transferred to the federal Court in Charleston West Virginia. Three transvaginal mesh multidistrict litigations involving various devices made by Boston Scientific, American Medical Systems and Johnson & Johnson’s Ethicon Inc. have been transferred to the federal Court in Charleston West Virginia and assigned to Chief Judge Joseph … [Read more...]
Catheter Recalls due to Serious Complications and Injuries
The benefits and usefulness of catheters are not in question, when the broad scope of applications and indications for which the devices are used are examined. Catheters are used for administering medications, injecting contrast dye for angiogram procedures, and removing small blood clots (thrombectomy) from arteries and … [Read more...]
Catheter Class I Recalls
Lawyers Investigate Boston Scientific Fetch 2 Aspiration Catheter Lawsuits. The product liability attorneys at Parker Waichman LLP are investigating possible lawsuits on behalf of clients who suffered an injury, allegedly due to a defective or recalled catheter. The firm, which has decades of experience representing clients in … [Read more...]
Judge Upholds Jury Award in Transvaginal Mesh Case
Transvaginal Mesh Injuries and Complications. A West Virginia federal judge denied Boston Scientific's request to vacate a 2014 multi-million dollar pelvic mesh verdict from 2014. U.S. District Judge Joseph R. Goodwin upheld the $14.3 million award in a medical device liability case involving Boston Scientific's Obtryx … [Read more...]
Boston Scientific Loses Verdicts
Boston Scientific Transvaginal Mesh Verdicts. Transvaginal mesh implants have become controversial in light of substantial evidence linking the devices to serious, sometimes permanent, complications. Boston Scientific is one of several manufacturers facing lawsuits over injuries related to pelvic mesh inserts. Transvaginal mesh … [Read more...]
$14.3M Verdict Against Boston Scientific
Injuries Allegedly Caused by the Boston Scientific Pelvic Mesh Devices. Three plaintiffs over injuries allegedly caused by the pelvic mesh devices. On October 3, 2016, a West Virginia federal judge rejected Boston Scientific Corp.'s appeal to overturn a $14.3 million award to three plaintiffs over injuries allegedly caused by the … [Read more...]
Boston Scientific Plaintiff Wins Appeal, Gets New Trial
A woman who lost her case in the Boston Scientific transvaginal mesh litigation more than two years ago is getting another opportunity in court. Previously, she filed a lawsuit alleging that she suffered injuries caused by the Pinnacle Pelvic Floor Repair Kit, which was implanted in 2010 to treat an anterior pelvic organ prolapse, 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...]
Feds Convene Grand Jury in Boston Scientific Transvaginal Mesh Investigation
Transvaginal Mesh Investigation Alleging Boston Scientific Schemed to Make Counterfeit Materials For Pelvic Mesh Devices. According to Mass Device, a grand jury has been impaneled in a case alleging Boston Scientific schemed to produce counterfeit materials for its pelvic mesh products. The federal government and the U.S. Food and … [Read more...]
Boston Scientific Transvaginal Mesh Investigation
Scientific Schemed to Make Counterfeit Materials For Transvaginal Mesh Investigation. According to Mass Device, a grand jury has been impaneled in a case alleging Boston Scientific schemed to produce counterfeit materials for its pelvic mesh products. The federal government and the U.S. Food and Drug Administration (FDA) are both … [Read more...]
Boston Scientific Investigated by FDA for Alleged Counterfeit Raw Materials in Vaginal Mesh Implants
FDA Examining Allegation That Boston Scientific Corp. Used Smuggled Materials. The U.S. Food and Drug Administration (FDA) is examining allegations that Boston Scientific Corp. used counterfeit raw materials smuggled from China to use in vaginal mesh implants. The mesh implants are used to treat urinary incontinence and various … [Read more...]
Boston Scientific Accused of Using Counterfeit Plastic in Transvaginal Mesh
A federal lawsuit filed under the Racketeering and Corrupt Organizations Act (RICO) alleges Boston Scientific conspired to use counterfeit plastic in their transvaginal mesh implant products. Transvaginal mesh is used to treat pelvic organ prolapse and stress urinary incontinence. It has become an increasingly controversial product … [Read more...]
Boston Scientific Recalls Chariot Guiding Sheaths Due to Risk of Shaft Separation
Medical device maker Boston Scientific has voluntarily recalled the Chariot Guiding Sheath worldwide because of the risk of shaft separation, which could cause permanent injury or death. The recall, which was initiated on November 19, 2015, affects all lot numbers of the Chariot Guiding Sheaths. A full list of lots numbers can be … [Read more...]
Boston Scientific Loses Verdict in Pelvic Mesh Litigation
Boston Scientific Biggest Transvaginal Mesh Verdict Ever. The largest transvaginal mesh verdict yet has been handed down to Boston Scientific in a lawsuit alleging the company failed to warn about the risks of the mesh device. Reuters reports that a Delaware jury ordered the company to pay $25 million in compensatory damages and $75 … [Read more...]
Jury Awards $100 Million in Boston Scientific Transvaginal Mesh Case
Late last week a Delaware jury ordered medical device maker Boston Scientific to pay $100 million to a woman who said she was injured by a transvaginal mesh device. The jury award contained $25 million in compensatory damages and an additional $75 million in punitive damages, Reuters reports. The devices are the subject of more … [Read more...]
Federal Judge Rules Punitive Damages Claims Can Stand in Lawsuit over Boston Scientific Pelvic Mesh Device
Product Liability Lawsuit Against Pelvic Mesh Device. A federal judge has ruled that punitive damage claims can stand in a product liability lawsuit against device maker Boston Scientific over its pelvic mesh products. In February 2010, the woman who brought the suit was implanted with Boston Scientific's Advantage Fit device to … [Read more...]
Boston Scientific Loses Bid to Remove Punitive Damages Claim in Pelvic Mesh Case
Boston Scientific failed in its bid to remove punitive damages claims in a pelvic mesh lawsuit this month, Mass Device reports. This case is one out of 15,000 product liability lawsuits filed over the devices, which are used to treat stress urinary incontinence. According to Mass Device, the plaintiff in the case alleged that she … [Read more...]
Justice Department Fines Medical Device Makers over $110 Million
The U.S. Department of Justice and U.S. Department of Health and Human Services released their joint annual report on health care fraud and abuse control on March 19th. According to the report, the federal government won or negotiated roughly $3.3 billion in judgments and settlements. Fines against medical device makers totaled over … [Read more...]
First Federal Trials over Boston Scientific Transvaginal Mesh Begin
Boston Scientific Transvaginal Mesh. Boston Scientific is facing the first federal trials over transvaginal mesh lawsuits, in which women allege that the pelvic mesh device is defective and caused injuries. According to Reuters, the federal trials are taking place in two courts; one in Charleston, West Virginia and the other in … [Read more...]
A Woman Says that Transvaginal Mesh by C.R. Bard, Boston Scientific Caused Injuries
Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices. Download FDA Update on the Serious Complications Associated with TVM Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a … [Read more...]
Georgia Woman’s Injuries Were Allegedly Caused by Johnson & Johnson, C.R. Bard, and Boston Scientific Transvaginal Mesh Products
Boston Scientific Transvaginal Mesh Products. Parker Waichman LLP, a national law firm dedicated to protecting the rights of victims injured by defective medical devices, has filed a lawsuit on behalf of a woman who experienced various adverse events after being implanted with several transvaginal mesh products. The lawsuit … [Read more...]
Boston Scientific Enteryx Device Side Effects
The FDA & Boston Scientific notified health care professionals and patients about serious adverse events, including death, occurring in patients treated with the Enteryx device. On September 23, 2005, Boston Scientific ordered a recall of all Enteryx Procedure Kits and Enteryx Injector Single Packs from commercial … [Read more...]
Some Implantable Defibrillators Are Defective
Implantable Defibrillators Are Defective. Boston Scientific is reporting problems with more of its implantable defibrillators. According to The Wall Street Journal, the company has advised physicians that three brands of the devices – Contak Renewal 3, Contak Renewal 4 and Vitality HE ICDs – may not work. All of the affected … [Read more...]
FDA Clears Remaining Recalled Boston Scientific Defibrillators
Recalled Boston Scientific Defibrillators. Boston Scientific has resumed sales of five defibrillators that had been the subject of a recall several months ago. In a regulatory filing, the company said the U.S. Food and Drug Administration (FDA) cleared changes to the Livian and Renewal cardiac resynchronization therapy … [Read more...]
Resume Sales of Cognis, Teligin Defibrillators
Resume Sales of Cognis, Teligin Defibrillators. Boston Scientific says its Cognis and Teligen defibrillators will be back on sale within 24 hours. Those devices were among the defibrillators recalled by Boston Scientific last month. According to The Wall Street Journal, the Food & Drug Administration (FDA) has approved two … [Read more...]
Shareholders Sue Over Boston Scientific Defibrillator Recall
Boston Scientific Defibrillator Recall. Boston Scientific is facing more fallout from its recent recall of implantable cardiac defibrillator and implantable cardiac resynchronization therapy defibrillator devices. This time, shareholders have filed suit claiming the company, along with some of its officers and directors, issued … [Read more...]
Boston Scientific Defibrillators Pose Dangers
Defibrillators May Cause Life-Threatening Shocks. Boston Scientific Corp.’s Cognis and Teligen brand defibrillators have a design flaw that can cause them to deliver unneeded, painful, and life-threatening shocks, according to an article in the journal HeartRhythm. The Wall Street Journal is reporting that the article’s authors say … [Read more...]
Boston Scientific Agrees to Settle Guidant Charges
Boston Scientific agreed to pay $296 million to settle another Justice Department probe. For the second time in a month, Boston Scientific has settled federal charges related to Guidant Corporation. Boston Scientific acquired Guidant in 2005. Last month, the Boston agreed to pay $296 million to settle another Justice Department … [Read more...]
Boston Scientific Taxus Stent Side Effects
Boston Scientific Taxus Stent. The Boston Scientific Taxus Express Stent was approved in March 2004 and has made the company into the largest coronary stent manufacturer in the U.S. The stent emits paclitaxel, a drug intended to inhibit restenosis caused by scar tissue growth. The stent uses a proprietary polymer, … [Read more...]
Boston Scientific Settles Probe Over Defibrillators
Probe Over Defibrillators Gets Settled. Last year we wrote that a prominent physician from the Minneapolis Heart Institute Foundation had expressed concern about test guidelines for a next-generation heart defibrillator under development at the time by Medtronic, Inc., Boston Scientific Corporation, and St. Jude Medical, Inc. Now, … [Read more...]
Test Guidelines for New Defibrillator Criticized
Test Guidelines For a New Defibrillator. Dr. Robert Hauser of the Minneapolis Heart Institute Foundation has said in today’s New England Journal of Medicine that he is not confident in the test guidelines for a next-generation heart defibrillator under development by Medtronic, Inc., Boston Scientific Corporation, and St. Jude … [Read more...]
Boston Scientific Stent Approved Despite Problems
Boston Scientific Stent Approved by The FDA. Late last week, Boston Scientific Corporation announced that U.S. health regulators approved the next-generation version of its widely used Taxus drug-coated stent. Boston Scientifc plans to begin selling the stent in early November. Meanwhile, in March, Boston Scientific received an … [Read more...]
Surgery Deemed More Effective Than Scientifics™ Taxus Stent
Taxus Stent Did Not Fare As Well As Surgery. Doctors are now reporting that Boston Scientific Corporation’s Taxus stent did not fare as well as bypass surgery in improving medical outcomes for the sickest patients with a build-up of fatty deposits in their arteries. After one year, 12.1 percent of bypass patients had died, … [Read more...]
NexStent Carotid Artery Stents Recalled
Defective stent delivery system causes recall. Boston Scientific said yesterday that it has recalled its NexStent products because of a defective stent delivery system. The Food & Drug Administration (FDA) has deemed the NexStent recall a Class I recall. Such recalls are for dangerous or defective products that predictably … [Read more...]
Guidant Defibrillators Maker Boston Scientific Agrees to Pay
Patients claim they were never informed about potential flaws in the defibrillators. Boston Scientific, the maker of Defective Implantable Guidant Heart Defibrillators, will pay $195 million to settle thousands of lawsuits filed by patients who said they were never informed about potential flaws in the defibrillators. the settlement … [Read more...]
Glitch prompts recall of Boston Sci Defibrillators
Issue might affect just a small subset of patients. Boston Scientific is recalling about 73,000 implantable cardiac defibrillators because of a problem with some device batteries, but a company official said Tuesday that the issue might affect just a small subset of patients with the devices. A notice posted Tuesday about 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...]
Boston Scientific confirms risk of blood clots in drug-coated stents
Risk Of Blood Clots Found In Patients Implanted With Drug-Coated Stents. Boston Scientific Corp. found a slightly higher risk of blood clotting in patients implanted with its newer drug-coated stents compared with older bare-metal versions, a company spokesman said Thursday. , The medical device maker reported the finding of its … [Read more...]
FDA Update Statement On Boston Scientific/Guidant Pacemakers And Defibrillators
Several models of pacemakers and implantable defibrillators should be removed. The FDA met last week with Boston Scientific/Guidant to discuss the firm's recent announcement that several models of pacemakers and implantable defibrillators should be removed from hospital inventories because they have the potential to malfunction due … [Read more...]
Boston Scientific Physician Communication Related to Products
Boston Scientific Corporation announced that it is providing safety information. Paul Donovan508-650-8541 Boston Scientific Corporation (NYSE: BSX) today announced that it is providing safety information and retrieving a specific subset of pacemakers, cardiac resynchronization pacemakers and implantable cardioverter defibrillators … [Read more...]
Boston Scientific Battery Problem in Some Devices
Boston Scientific admits some implantable cardiac devices have battery problems. Boston Scientific Corp on Monday said it had notified doctors that some of its implantable cardiac devices, which it acquired as part of its purchase of Guidant Corp. last month, could be at risk for early battery depletion. Boston Scientific, whose … [Read more...]
Boston Scientific Recalls Flextome Angioplasty Device
Flextome Angioplasty Device Recalled. The U.S. Food and Drug Administration (FDA) and Boston Scientific Corporation have notified healthcare professionals regarding the class 1 recall of an angioplasty device (Flextome Cutting Balloon Device and Monorail Delivery System), due to the potential for distal catheter shaft separation … [Read more...]
Boston Scientific Shares Dip on Letter News
Regulatory Problems In Medical Devices Shipped From Quincy, Mass. Federal regulators sent Boston Scientific Corp. a warning letter identifying "serious regulatory problems" in medical devices shipped from a Quincy, Mass., distribution plant, including heart stents sent to hospitals despite a quality control problem. The U.S.Food … [Read more...]
Boston Scientific Recalls Device After FDA Warning
Boston Scientific Device Recalls. Hundreds of patients may need surgery to remove an implanted drug-injection device made by Boston Scientific Corp., the company said yesterday after federal regulators cited it for quality-control problems. A spokesman for the … [Read more...]
FDA Reviews Boston Scientific Acid Reflux Device After Death
Death After Treated with a Boston Scientific Corp. Acid Reflux Device. The Food and Drug Administration is reviewing the death last month of an elderly woman after she was treated with a Boston Scientific Corp. device for acid reflux disease. The FDA is also looking at injuries in six other patients treated with the Enteryx … [Read more...]
The Wrong Way to Run a Recall
System for inserting the stent into a patient's artery. Boston Scientific's (BSX) handling of its recent coronary stent recall is a case study in how not to respond to a product failure. Since early July, the company has been forced into not one, but three, occurrence . Because of a manufacturing glitch, now apparently fixed, the … [Read more...]
Stent System Recalled After Defect Is Found
Voluntary recall of two batches of its new drug-coated coronary stent system. Boston Scientific Corp. yesterday announced a voluntary recall of two batches of its new drug-coated coronary stent system after a defect was linked to one death and 16 "serious" injuries. The company's senior executives called the recall a precautionary … [Read more...]
