The US Food and Drug Administration (FDA) has alerted patients, caregivers and healthcare providers about the potential need for early device replacement of Boston Scientific’s Accolade pacemakers—including the Accolade, Proponent, Essentio and Altrua 2 Standard Life (SL) and Extended Life (EL) pacemakers, and the Visionist and Valitude cardiac resynchronisation therapy pacemakers.
In a safety communication sent out on 16 December, the regulator notes that Boston Scientific has announced a recall for a subset of Accolade pacemaker devices that carry an increased risk of permanently entering ‘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.
The communication details that 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. It also states that a device that enters Safety Mode should be replaced.
“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,” the safety communication adds.
The regulator has recommended that healthcare providers: review Boston Scientific’s recent recall notice pertaining to a subset of these Accolade pacemaker devices; be aware that the FDA is working with the manufacturer to evaluate the potential risk of this issue in all Accolade pacemaker devices; and report any problems their patients experience with Accolade pacemaker devices to the FDA.
The Accolade devices are a family of pacemakers and cardiac resynchronisation therapy pacemakers that are implanted to treat arrhythmias, and moderate-to-severe heart failure.
Additional information, including recommendations for patients and caregivers, and further details about the potential need for the early replacement of Accolade pacemaker devices, can be found within the FDA’s original safety communication.
