FDA Provides Update on Medtronic’s Recall of Its Cobalt and Crome Defibrillators

The FDA has issued an update on Medtronic’s June 22 recall of its Cobalt XT, Cobalt and Crome implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, deeming it a Class 1 recall because of the risk of serious injury or death.

The recall was prompted by reports of a short circuit protection alert resulting in the delivery of a reduced-energy shock in a second phase of therapy.

A reduced-energy electrical shock may fail to correct an irregular heartbeat/arrythmia or may cause an irregular heartbeat, the FDA said, adding that an inaccurate response to a short circuit protection alert could cause serious injury or death.

The 87,709 affected products were distributed from Feb. 3, 2020 to the time of the recall. There have been 27 complaints but no injuries or deaths associated with this issue so far, the agency said.