FDA Alerting About Potential Need For Early Device Replacement Of Boston Scientific Accolade Pacemaker Devices; Boston Scientific Announced Recall For Subset Of Accolade Pacemaker Devices With Increased Risk To Permanently Enter Safety Mode

Benzinga · Dec 17 00:25

Date Issued: December 16, 2024

The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and health care providers about the potential need for early device replacementof Boston Scientific Corporation (Boston Scientific) Accolade pacemaker devices, which includes the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) 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...

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FDA Alerting About Potential Need For Early Device Replacement Of Boston Scientific Accolade Pacemaker Devices; Boston Scientific Announced Recall For Subset Of Accolade Pacemaker Devices With Increased Risk To Permanently Enter Safety Mode

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