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 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 announced multiple recalls but has said its battery issues were limited. One internal test in 2025 found batteries with an “extremely high failure rate.” Credit...Illustration by Mel ...
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 ...
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 ...
Highest-risk classification: FDA labeled Boston Scientific’s pacemaker recall as Class I, the most serious, due to potential for injury or death. Software fix required: Devices remain in use but need ...
The U.S. Food and Drug Administration has issued an urgent safety alert after an electric malfunction in some older Boston Scientific pacemakers was linked to two reported deaths and early device ...
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