More than 60,000 pacemakers are being recalled because moisture may be able to get inside of the devices, potentially causing them to short out or experience a drop in battery life. The FDA notes that this is a ‘Class I’ recall, which is its most serious type of recall classification — one reserved for issues that may lead to ‘serious injuries or death.’
The recall comes from Abbott, which was previously known as St. Jude Medical, and it involves some Assurity and Endurity implantable pacemakers. A total of 61,973 of these devices have been recalled because, according to the company, ‘a small number of devices’ have had issues with moisture getting inside.
When this happens, the moisture may cause an electrical short, which could then result in faster battery drain, telemetry errors and failure, loss of the ability to pace the patient’s heartbeat, and a reduced duration between when the device first warns that its battery is depleted and the pacemaker’s end of service.
The recalled pacemakers were made using ‘specific equipment,’ according to the recall notice, and they were distributed between April 2015 and February 2019. The shortened battery life may, the company notes, result in the pacemaker needing to be replaced sooner than usual.
As well, a pacemaker that loses the ability to deliver pacing could lead to heartbeat issues, such as an irregular heart rate, as well as related problems like dizziness, shortness of breath, and fainting. The recall notice states there have been 135 injuries and complaints about this issue, but no reported deaths.
Patients who may have one of these recalled pacemakers received a letter about the potential issue and details on how to proceed, the list of which can be found on the FDA’s website here.