Boston Scientific Recalls Accolade Pacemakers Amid Safety Concerns

Boston Scientific has issued a recall for certain Accolade pacemakers due to a malfunction that can cause the devices to enter permanent safety mode, limiting their ability to regulate heartbeats effectively. The recall, now classified as a Class I event by the FDA, has been linked to 832 injuries and two deaths. The affected pacemakers, manufactured before September 2018, may experience battery underpowering issues that compromise their functionality. Patients with these devices are advised to work closely with their healthcare providers to monitor for signs of malfunction through remote monitoring or regular office visits.

The recall includes multiple models within the Accolade family, as well as Proponent, Essentio, Altrua 2, Visionist, and Valitude pacemakers. If a device enters safety mode, it may require surgical replacement to prevent potential health risks. The FDA continues to collaborate with Boston Scientific to assess whether the issue extends beyond the identified subset of devices. Patients with affected pacemakers should consult their doctors to determine the best course of action for ongoing monitoring and potential device replacement.