The FDA is further elevating a pacemaker recall from Boston Scientific that it first broadcast in December over certain Accolade implants that can place themselves into a permanent safety mode and may need to be removed and replaced.
At that time, the agency and Boston Scientific reported two deaths related to the issue that stemmed from a no-longer-used battery manufacturing process that could weaken the pacemaker’s power output during certain operations, pushing the system to reset itself.
Tallying three resets within a 48-hour period will also trigger the device to enter a limited safety mode and cause it to deliver therapy under a set of backup parameters instead of the cardiac programming designed to meet the patient’s needs.
This can result in abnormally slow heartbeats, fainting and death, according to the agency.
The recall—which the FDA has since categorized as Class I, its most serious—affected multiple standard- and extended-life pacemakers in the Accolade family, including the Proponent, Essentio and Altrua 2 models as well as the Visionist and Valitude cardiac resynchronization therapy implants.
In addition to the previously disclosed two deaths, the FDA said in its Feb. 21 update that the issue has also been linked to 832 patient injuries.
All affected devices—estimated to be about 156,000 units worldwide, or about 13% of the total number in use—were manufactured before September 2018. In its December notice (PDF) to healthcare providers, Boston Scientific said the risks of the battery issue increases as it enters the remaining four years of its projected lifetime.