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 ...

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 certain battery production techniques could lead to higher electrical impedance, raising the risk that the devices may be pushed into a limited safety mode. (Photo by Sarah ...

As of March 18, four patients have died, and 2,557 serious injuries have been reported by Boston Scientific in patients with Accolade pacemakers. The company has issued a correction to affected ...

In addition to the previously disclosed two deaths, the FDA said in its February 21 update that the issue has also been linked to 832 patient injuries. (Sarah Silbiger/Stringer/Getty Images News) The ...

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 Food and Drug Administration said Boston Scientific will upgrade certain pacemakers to a new software as part of a recall. Boston Scientific issued a letter to affected customers recommending all ...

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 ...

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 ...

In 1992, an episode of the iconic TV show Law & Order aired a storyline that now feels eerily prescient. The episode revolved around a teenage boy who dies due to a faulty pacemaker. As detectives dig ...

A prominent European court has ruled that Boston Scientific’s German branch is responsible for paying the surgical costs associated with replacing faulty implantable devices made by one of the company ...