Boston Scientific announced multiple recalls but has said its battery issues were limited. One internal test in 2025 found ...

The FDA is boosting a recall effort from Boston Scientific regarding batteries potentially underpowering a number of the company’s implanted Accolade pacemakers, which may need to be replaced earlier ...

Boston Scientific has announced it has received FDA approval its INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers, according to a news release. The INGENIO and ...

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 ...

Boston Scientific has recalled its Accolade pacemaker devices due to a manufacturing issue that could cause the devices to enter safety mode, requiring replacement. The FDA has classified the recall ...

Boston Scientific (NYSE:BSX) announced Saturday that its pivotal clinical trial for the modular cardiac rhythm management (CRM) system, which comprises its EMPOWER leadless pacemaker, met all safety ...

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 ...

FDA yesterday published a safety communication indicating the potential need for Boston Scientific Accolade pacemaker devices to be replaced early after finding a manufacturing issue with the battery ...

TUESDAY, Feb. 25, 2025 (HealthDay News) -- Boston Scientific has issued a recall of Accolade pacemaker devices, according to a safety communication from the U.S. Food and Drug Administration. The ...

BRUSSELS, March 5 (Reuters) - U.S. medical device maker Boston Scientific Corp's German arm is liable for the cost of operations to replace potentially defective pacemakers, Europe's top court ruled ...

Boston Scientific Corporation BSX recently presented favorable six-month results from the ongoing pivotal MODULAR ATP clinical trial of the mCRM System — the first modular cardiac rhythm management ...