Boston Scientific Recalls Accolade Pacemaker Devices

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Boston Scientific has issued a recall of Accolade pacemaker devices, according to a safety communication from the U.S. Food and Drug Administration.

The Accolade devices under recall include the Accolade, Proponent, Essentio, and Altrua 2 Standard Life and Extended Life pacemakers and the Visionist and Valitude cardiac resynchronization therapy pacemakers.

The devices are being recalled due to an increased risk for permanently entering Safety Mode. Safety Mode has limited functionality and is associated with the pacemaker being unable to properly regulate the heart’s rhythm and rate in some patients. Devices that enter Safety Mode need to be replaced.

Due to a manufacturing issue, the battery underpowers the device and causes the device to permanently enter Safety Mode. The FDA is working with the manufacturer to assess the risk for this issue in all Accolade pacemaker devices and to pinpoint additional mitigation strategies as needed.

Serious adverse health consequences, including slow heartbeats, fainting, and death, may be caused by the recalled devices. So far, 832 injuries and two deaths have been reported.

Physicians and patients should work together to monitor Accolade pacemaker devices. For patients at high risk for harm associated with interrupted pacing that may occur with Safety Mode, the device should be immediately replaced. For other patients, nonurgent replacement is recommended. Any problems encountered with Accolade pacemaker devices should be reported to the FDA.

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Source: HealthDay

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