Massive Pacemaker Recall After Deaths; U.S. Doc on Hantavirus Cruise; Deadly Misinfo

Massive Pacemaker Recall After Deaths; U.S. Doc on Hantavirus Cruise; Deadly Misinfo

(MedPage Today) -- Note that some links may require registration or subscription. The FDA issued a notice about Boston Scientific's massive recall of Accolade, Essentio, Proponent, and other pacemakers affected by a software issue linked to four...

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-related battery issue that could cause affected devices to enter Safety Mode and limit pacing functionality. The correction does not involve removing devices but requires clinicians to upgrade the pacemakers’ software to reduce the risk of premature…

Boston Scientific Accolade Pacemaker Recall Issued After Thousands of Injuries: FDA

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US FDA issues recall of Boston Scientific heart devices - Regional Media News

May 7 (Reuters) - Boston Scientific has issued an urgent recall to correct several heart devices after the U.S. Food and Drug Administration classified the action as its most serious recall, the regulator said on Thursday. Here are some details: • The recall does not require the devices to be removed from patients or pulled from sale. Instead, doctors are being told to update the devices' software during an in-person clinic visit, the FDA said. …