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- ...

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

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 ...

May 7 (Reuters) - Boston Scientific has issued an urgent recall to correct several heart devices after the U.S. Food and Drug ...

Health news and commentary gathered by MedPage Today staff ...

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 ...

The Food and Drug Administration has a big warning going out about pacemakers this morning. There are half-a-million people out there with pacemakers vulnerable to hackers who might be able to switch ...

In a paper in JAMA this week, two experts highlight lessons that could be learned from the US Food and Drug Administration's (FDA) first major cybersecurity-related recall for a permanent implantable ...

Medical device maker Abbott on Monday announced it is voluntarily recalling some 465,000 pacemakers to install a firmware update to patch cybersecurity vulnerabilities in the devices. The recall ...