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, 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 devices are being recalled due to an increased risk for permanently entering Safety Mode. HealthDay News — Boston Scientific has issued a recall of Accolade pacemaker devices, according to a ...

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 ...

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 said in the letter that it is actively developing a software update for the affected devices designed to detect on the onset of a high impedance battery state and display an alert.

The FDA is further elevating a pacemaker recall from Boston Scientific that it first broadcast in December over certain Accolade implants that can place themselves into a permanent safety mode and may ...

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 ...

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 ...