FDA Issues Safety Communication for Some Accolade Pacemakers

Several brands of Boston Scientific pacemakers are under recall due to a risk that the devices can permanently enter Safety Mode, according to an alert issued by the US Food and Drug Administration.

The affected devices are all part of the Accolade family of devices, including the Accolade, Proponent, Essentio, and Altrua 2 Standard Life and Extended Life pacemakers, as well as the Visionist and Valitude cardiac resynchronization therapy pacemakers.

In the safety communication released today, the FDA says it is “aware of a manufacturing issue with the cathode of some Accolade pacemaker device batteries that may lead to underpowering the device system and may cause the pacemakers to permanently enter Safety Mode, which requires pacemaker replacement.”

According to Boston Scientific, the recall affects a subset of approximately 13% of devices from the Accolade line of pacemakers that were built before 2018 and are no longer being implanted. They note that two deaths have been reported in pacemaker-dependent ambulatory patients implanted with devices that initiated Safety Mode and led to loss of pacing. Other potential clinical harm scenarios are pacing inhibition/pauses, muscle stimulation, and heart failure decompensation. Most of the Safety Mode events have occurred in office settings during pacemaker interrogation.

When a device enters Safety Mode, Boston Scientific says emergent replacement should be performed for patients who are at risk of harm. For others, nonemergent replacement is recommended with consideration given to how much the individual patient relies on pacing.