Medtronic Class 1 Recall of Pace Makers

Medtronic has begun a Class 1 recall of its Cardiac Resynchronization Therapy with Defibrillation and Implantable Cardiovert-Defibrillators due to a defect in the manufacturing process. The devices are intended to provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. Affected devices have product codes NIK and LWS, and they were manufactured between 7/13/2013 and 8/8/2017.

A recall notice says the manufacturing defect causes an out-of-specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. “The delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death,” it says.