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 the Accolade family, built before September 2018—representing 13% of the devices in the product line. An Accolade pacemaker that enters Safety Mode should be replaced.
Be aware: There have been 2 reported deaths in patients with devices that initiated Safety Mode in an ambulatory setting. Urgent care clinicians should be aware of the device’s potential issue and consider asking patients with pacemakers about their devices, especially when symptoms are present. Additional information for healthcare providers is available in the Boston Scientific advisory. If the pacemaker appears to have functional problems, patients and providers are encouraged to submit a report on the FDA website.