On December 16, 2024, the Food and Drug Administration (FDA) announced a recall of certain Boston Scientific Accolade pacemaker devices. According to FDA, the devices present an increased risk of permanently entering Safety Mode, which limits the pacemaker’s functions, preventing it from being able to regulate the heart’s rhythm and rate in some patients. FDA says the risk comes from a manufacturing issue, in which the battery underpowers the system. The recalled devices are in …
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