American Hospital Association

FDA issues most serious recall for certain pacemaker devices by Boston Scientific

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 to Update Pacemakers in Recall, FDA Says

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 ...
WBJournal

After two patient deaths, Boston Scientific recalls pacemaker

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 ...
Hosted on MSN

FDA issues highest-risk recall for Boston Scientific pacemakers

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

FDA says Boston Scientific Accolade pacemakers may need early replacement

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 ...