Boston Scientific Accolade Pacemaker Recall Issued Due to Early Failure Risks

Federal health officials are warning that recently recalled Boston Scientific pacemaker devices may begin to malfunction as the battery nears the end of its life cycle, indicating that the defect has been already been linked to at least two fatalities.

The U.S. Food and Drug Administration (FDA) issued a safety communication on December 16, warning that certain Boston Scientific Pacemakers may begin to malfunction and cause the devices to enter “Safety Mode,” which severely limits its functionality and prevents the pacemaker from properly regulating the heart’s rhythm and rate.

The manufacturer said the affected devices have a higher concentration of lithium salts in the battery cathode, which can lead to the Safety Mode issue. To date, two implant recipient deaths have been reported in connection with the Safety Mode problems.

The recalled Accolade devices are a set of pacemakers and cardiac resynchronization pacemakers, which are implanted into a patient’s chest to treat abnormal heartbeat and to provide life-saving support in the event of severe heart failure.

Accolade Pacemaker Battery and Safety Mode Problems

In an Urgent Medical Device Notice issued this month, Boston Scientific told customers that the Accolade pacemakers can experience voltage decreases, which can cause the system to reset and the power to be interrupted. If three resets occur in 48 hours the device will enter Safety Mode.

The manufacturer indicates the affected devices have a high likelihood of lapsing into Safety Mode if it has approximately four years or less of remaining battery life.

While the devices provide backup pacing support in Safety Mode, they are not designed for full-time chronic pacing, and may fail to provide optimal support for a patient’s cardiac condition.

The FDA and Boston Scientific say the problem affects roughly 13% of all devices built before September 2018. The recall reportedly affects the Accolade, Proponent, Essentio and Altrua 2 dual chamber (DR) standard life (SL) and DR extended life pacemakers, as well as Visionist and Valitude cardiac resynchronization therapy pacemakers (CRT-Ps).

Boston Scientific reports it is refining the techniques used to reduce lithium salt concentrations and improve the performance of batteries in the pacemaker devices. The company also claims it is developing a software update for the Accolade family of devices designed to detect when battery power loss will occur and provide an alert so patients can have their devices replaced.

The FDA indicates it plans to continue to work with Boston Scientific to make sure patients and doctors are aware of the issue and determine if patient intervention or action is needed. The agency also said it will continue to monitor device performance and reports of side effects and keep the public informed of new information.

Patients who have the device implanted should contact their doctor with questions and next steps. Side effects in connection with the problem should be reported to the FDA’s MedWatch Adverse Event Reporting Program.