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- ...

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

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 ...

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 announced it has received FDA approval its INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers, according to a news release. The INGENIO and ...

FDA yesterday published a safety communication indicating the potential need for Boston Scientific Accolade pacemaker devices to be replaced early after finding a manufacturing issue with the battery ...

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 ...

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 ...