Boston Scientific Pacemaker Recall Comes After Hundreds of Injuries, Two Deaths Reported

The FDA indicates that problems with the recalled Accolade pacemakers and other devices made by Boston Scientific warrant a Class I designation, due to the serious risks of patient injuries and deaths.

Federal regulators issued an update for a Boston Scientific pacemaker recall, after problem with Accolade, Proponent, Essentio, Altrua and other related devices may have contributed to at least two deaths and hundreds of reported injuries.

The U.S. Food and Drug Administration (FDA) released a safety communication on February 21, warning that a previous pacemaker recall has been upgraded to a class I designation, indicating that continued use of the devices made by Boston Scientific pose a serious threat of injury or death to patients.

Boston Scientific first issued a recall for the pacemakers on December 16, 2024, impacting Accolade, Proponent, Essentio, and Altrua 2 Standard Life and Extended Life pacemakers and the Visionist and Valitude cardiac resynchronization therapy pacemakers; all of which are part of the Accolade product line.

The pacemakers are part of a family of cardiac resynchronization therapy devices, which are implanted into the chest to treat an abnormal heartbeat and heart failure.

At least two deaths and 832 injuries were reported in connection with the pacemaker recall, according to a notice issued by Boston Scientific.

The Boston Scientific pacemakers were recalled because an issue with the batteries may result in a lack of power. This can cause the pacemakers to permanently enter Safety Mode, which does not allow the pacemaker to fully function and will not allow the device to regulate the rhythm of the heart in some patients.

When one of the affected pacemakers enters Safety Mode, the patient is at high risk and the device must be replaced. However, Safety Mode can only be identified during a doctor’s office visit or through remote monitoring by a doctor’s office using the Boston Scientific Latitude Communicator System.

Accolade Pacemaker Recall Recommendations

The FDA warns that the recalled devices, which may still be implanted in many patients, may need early replacement because of the malfunctioning Safety Mode.

The agency recommends patients work with their doctor to monitor the affected pacemaker and discuss if they are a candidate for remote monitoring, which would review regular updates and alerts from the device. Patients can then discuss a plan for surgery to remove the pacemaker and implant a new device.

The recommendations also urge patients to talk to their doctor about new or worsening symptoms, including lightheadedness or loss of consciousness.

The FDA is working with the manufacturer to evaluate the risk of the issue in all affected Boston Scientific pacemakers. Meanwhile Boston Scientific says it plans to make changes to the batteries that will address the problem. The company is also developing a software update to detect the battery health in all affected pacemaker devices.

Anyone who has experienced any side effects linked to the use of Boston Scientific pacemakers should seek medical treatment and report the event to the FDA’s MedWatch Adverse Event Reporting Program.