FDA Releases Alert About Early Device Replacement of Boston Scientific Pacemakers

The FDA is releasing an alert about the “potential need for early device replacement of 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 the recall “or 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’s rhythm and rate in some patients. A device that enters Safety Mode should be replaced.”

Patients and caregivers should “continue to work with [their] healthcare provider to monitor [their] Accolade pacemaker device, either remotely or during [their] existing in-office follow-up schedule.” They are also advised to discuss their “current pacing needs” and their risks if the device goes into Safety Mode, and if they are determined to be at high risk of harm, they could look into replacing the device.

Healthcare providers should “review the recall notice” and remain alert for further updates from the FDA and the manufacturer. Pacemakers that enter Safety Mode require replacement because “Safety Mode offers limited functioning of the pacemaker and has been associated with the pacemaker being unable to properly regulate the heart’s rhythm and rate in some patients. Safety Mode can only be identified through office visits or through remote monitoring using the Boston Scientific Latitude Communicator system.”