The U.S. Food and Drug Administration (FDA) is alerting patients, caregivers, and healthcare providers about the potential need for early replacement of certain Boston Scientific Accolade pacemaker devices. This includes the Accolade, Proponent, Essentio, and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, as well as the Visionist and Valitude cardiac resynchronization therapy pacemakers.
Boston Scientific has issued a recall for a specific group of Accolade pacemaker devices with an increased risk of permanently entering Safety Mode. In this mode, the pacemaker’s functionality is limited, which may cause it to fail in properly regulating the heart’s rhythm and rate in some patients. A pacemaker that enters Safety Mode should be replaced. The increased risk of entering Safety Mode is linked to a manufacturing defect that causes the battery to underpower the device.
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