UPDATE: Feb. 25, 2025: Boston Scientific’s recall of Accolade pacemakers has been connected to 832 injuries and two deaths.
The Food and Drug Administration labeled the recall a Class I event, the severest classification, and posted a recall notice on Friday. The FDA said the recall may require devices to be removed from patients.
Boston Scientific notified customers of the recall and safety risks with certain Accolade pacemakers in December, and the FDA published an alert on the action. At the time, Boston Scientific noted the two deaths associated with the recall but did not specify the number of injuries.
About 203,000 devices from the Accolade family of pacemakers built before September 2018 are affected globally, a Boston Scientific spokesperson wrote in an email. The company did not specify the number of affected devices in its December recall letter
Dive Brief:
- Boston Scientific has recalled a group of Accolade pacemakers because of a malfunction that can permanently put devices in safety mode, limiting functionality and preventing devices from properly treating patients. The Food and Drug Administration said devices that permanently enter safety mode must be replaced.
- The recall has been tied to two deaths. Boston Scientific did not specify the number of injuries in its December recall notice. The FDA posted an alert for the recall on Monday.
- The subset of affected Accolade devices includes Accolade, Proponent, Essentio and Altrua 2 standard life and extended life pacemakers, as well as Visionist and Valitude cardiac resynchronization therapy pacemakers, according to the FDA’s notice.
Dive Insight:
The Accolade pacemakers are implantable devices used to treat irregular heartbeats and moderate to severe heart failure. Pacemakers use electrical stimulation to help maintain the rate and rhythm of a patient’s heartbeat.
Boston Scientific has recalled a subset of Accolade pacemakers due to the malfunction risk. Devices that permanently enter safety mode have limited functions and cannot properly regulate some patients’ heartbeats.
The risk of pacemakers permanently entering safety mode is due to the battery underpowering the system because of a manufacturing issue.
Patients and physicians can only detect if the safety mode has been triggered through office visits or through remote monitoring, according to the agency’s notice. The FDA recommends that patients work with their doctors to monitor devices either in-office or remotely. Remote monitoring will alert providers if a device enters safety mode. If a patient is not eligible for remote monitoring, they should establish a regular in-office monitoring schedule.
Patients and physicians will need a plan for surgery to replace devices that have entered safety mode. Doctors can also contact patients about removal if it's determined there’s a high risk of harm if a pacemaker enters safety mode.
Boston Scientific, in its recall letter, did not state how many devices were affected by the recall, only that approximately 13% of Accolade pacemakers built before September 2018 are included in the advisory population. The FDA is working with Boston Scientific to identify if the issue affects all Accolade pacemakers, not just a subset.
