Boston Scientific Recalls Pacemakers

Boston Scientific is recalling (Class 1) its Accolade pacemakers and Visionist and Valitude cardiac resynchronization therapy pacemakers because of the possibility for them to enter “Safety Mode” during remote data collection (telemetry). “If the device enters Safety Mode, early device replacement is needed,” a recall notice says. “Once a device enters Safety Mode, it cannot be reversed and may cause these devices to only provide unipolar sensing and pacing, which can lead to serious injury or death due to interruption of pacing.” To date, there have been 832 reported injuries and two reports of death, the notice says.

The Accolade pacemakers are intended to treat slow heart rhythms (bradyarrhythmias) by providing dual-chamber (atrial and ventricular) and adaptive rate pacing. The Visionist and Valitude devices provide cardiac resynchronization therapy to manage heart failure by coordinating ventricular contractions through biventricular electrical stimulation.