FDA announces Class I recall of Boston Scientific pacemakers—replacement may be necessary
According to the U.S. Food and Drug Administration (FDA), safety issues with certain Boston Scientific pacemakers are significant enough that the situation has been categorized as a a Class I recall. This means the devices “may cause serious injury or death” if used without following the agency's instructions.
These concerns were first reported to the public in December. They have been linked to more than 800 injuries and two deaths.
The FDA's recommendations do not seem to have changed since the agency initially detailed this issue.
The reason behind the Class I recall
Several Boston Scientific pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps) have been associated with a heightened risk of entering into Safety Mode, a feature intended to only be used during critical failures when three power-on resets are required within 48 hours due to battery issues. If these devices do enter Safety Mode, it creates a situation where the device will need to be removed and replaced.
“Once a device enters Safety Mode, it cannot be reversed and may cause these devices to only provide unipolar sensing and pacing, which can lead to serious injury or death due to interruption of pacing,” the FDA warned. “Devices in the Accolade family of pacemakers and CRT-Ps have an increased chance to enter Safety Mode during remote data collection (telemetry) or other higher-powered operations.”
Devices included in this recall include Boston Scientific’s Accolade, Proponent, Essentio and Altrua 2 dual-chamber standard life and dual-chamber extended life pacemakers as well as the company’s Visionist and Valitude CRT-Ps.
Patients are advised to work with their healthcare provider to determine next steps. If the patient is a candidate for remote monitoring, their clinicians should receive regular updates, including notifications if the device enters Safety Mode. In addition, if it is determined that a patient faces an especially high risk of harm if the devices enters Safety Mode, it may be necessary for the devices to be replaced.
Safety issues first announced to the public in 2024
Boston Scientific first detailed these safety concerns in December. At the time, the company noted that approximately 13% of its family of Accolade pacemakers built before September 2018 were impacted by this issue. Because the devices were built in 2018, Boston Scientific explained, all devices included in this alert have already been implanted; there are no unused devices remaining.
The FDA sent out an urgent alert at the time to inform clinicians and patients alike about these problems, but it had not ruled this a Class I recall.
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Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.