The FDA has issued a safety alert for several models of Boston Scientific’s Endotak Reliance defibrillation leads after identifying a serious defect linked to 16 deaths and 386 injuries. The leads, ...
A Food & Drug Administration panel approved a Boston Scientific Corp. (NYSE:BSX) bid to expand the indication of its cardiac resynchronization therapy defibrillators to cover patients suffering from ...
Guidant, a subsidiary of Natick, Mass.-based Boston Scientific, has agreed to pay $9.25 million to settle False Claims Act charges over the company’s alleged cost inflation for pacemakers and ...
Boston Scientific, a Marlborough medical device manufacturer, has recalled a subset of its Accolade pacemakers due to battery issues leading to malfunctions, where two patient deaths have been ...
The U.S. Food and Drug Administration is warning patients and doctors about possible issues seen with Boston Scientific heart devices. The FDA issued alerts on Aug. 6 about the Marlboro-based ...
In a safety communication dated December 16 posted to the site of the FDA, the agency stated: “The U.S. Food and Drug Administration is alerting patients, caregivers, and health care providers about ...
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