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 ...

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 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 ...

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 ...

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 ...

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 ...