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 the potential need for early device replacement of Boston Scientific (BSX) Corporation Accolade pacemaker devices, which includes the Accolade, Proponent, Essentio, and Altrua 2 Standard Life and Extended Life pacemakers, and the Visionist and Valitude cardiac resynchronization therapy pacemakers. Boston Scientific announced a recall for a subset of Accolade pacemaker devices with an increased risk to permanently enter Safety Mode, which has limited functionality and has been associated with the pacemaker being unable to properly regulate the heart’s rhythm and rate in some patients… While the recall by Boston Scientific identifies a subset of Accolade pacemaker devices with increased risk of entering Safety Mode, the FDA is working with the manufacturer to evaluate the potential risk of this issue in all Accolade pacemaker devices and identify additional mitigation strategies as needed. The FDA is issuing this communication to raise awareness of the manufacturer’s recall notice, the FDA’s ongoing evaluation with the manufacturer of the issue, and the FDA’s current recommendations.”
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