The US Food and Drug Administration (FDA) has classified Boston Scientific’s recall of Accolade pacemaker devices as Class I, the most serious type.
In the FDA notice, the agency disclosed 832 injuries and two patient deaths related to the safety issues. The affected devices include some models of Accolade, Proponent, Essentio, and Altrua 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers along with Visionist and Valitude cardiac resynchronization therapy pacemakers (CRT-Ps).
Manufacturing issues cause recall
Boston Scientific has cited manufacturing issues as the reason for the recall. The affected devices are at an increased risk of entering “Safety Mode” during telemetry (data collection) or other normal, high-power operations. The company noted that its devices are intended to enter Safety mode during critical device component failures, where “the device experiences three power-on resets within 48 hours due to battery issues”.
The company added that once a device enters Safety Mode, it cannot be reversed and the affected device “must be removed or replaced” as it can cause health issues due to interruption of pacing. The use of affected devices may cause serious adverse health consequences, such as serious injury including slow heart rate, fainting, and death.
Boston Scientific first issued the recall for the pacemaker devices back in December 2024. In the notice, the company noted that approximately 13% of devices from the ACCOLADE family, built before Sep 2018 were affected. Adding that the company is “actively developing a software update” to detect the onset of a high impedance battery state, which is associated with a high risk of the device entering Safety Mode, in all Accolade pacemaker devices.
The notice recommends immediate replacement of any devices in safety mode that are implanted in patients who are at high risk of harm associated with interrupted pacing that may occur with Safety Mode. A non-urgent replacement for other patents.
The FDA has also advised scheduling a device replacement “when the battery life remaining reaches four years or if the remaining battery life is already less than four years”. Adding that users should not rely on battery life estimates in safety mode and should conduct system follow-ups at least once every 12 months.
