Boston Scientific recalls pacemakers due to battery issues causing safety mode activation linked to 4 deaths and 2,557 serious injuries, FDA reports.

The Food and Drug Administration has issued a Class I recall correction for certain Boston Scientific ACCOLADE pacemakers and cardiac resynchronization therapy pacemakers after identifying a software- ...

As of March 18, Boston Scientific has reported four deaths and 2,557 serious injuries associated with this issue, the FDA said. "The FDA has identified this recall as the most serious type. This ...

Pacemaker safety recall: FDA recalled certain Boston Scientific pacemakers due to a software flaw linked to deaths and serious injuries, advising in-clinic software updates. Widespread Salmonella risk ...

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 ...

Highest-risk classification: FDA labeled Boston Scientific’s pacemaker recall as Class I, the most serious, due to potential ...

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 ...