Boston Scientific Warns of Potential Need to Replace Some Accolade Pacemakers Early

The U.S. Food and Drug Administration (FDA) issued an alert about the possible need for early device replacement of Boston Scientific’s Accolade pacemakers. These include 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 issued a recall for a subset of Accolade pacemakers with a higher risk to permanently enter Safety Mode, which has limited functionality and has been related to the pacemaker being unable to properly regulate the heart’s rhythm and rate in some patients.

The company said a device that enters Safety Mode should be replaced. The increased risk of permanently entering Safety Mode in this subset of Accolade pacemaker devices is due to the battery underpowering the system because of a manufacturing issue.

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.

While the recall by Boston Scientific identifies a subset of Accolade pacemaker devices with increased risk of entering Safety Mode, the FDA is working with the manufacturer to evaluate the potential risk of this issue in all Accolade pacemaker devices and identify additional mitigation strategies as needed.

Boston Scientific plans to implement updated manufacturing work instructions for the process used to make the cathodes for Accolade product batteries. In addition, the manufacturer is developing a software update to detect battery health in all Accolade pacemaker devices.