There have been no injuries or deaths associated with the recall.
“A reduced-energy electrical shock may fail to correct an irregular heartbeat or may cause an irregular heartbeat,” the FDA said in a news release. A software update is currently available, a Medtronic spokesperson told Becker’s.
The Minneapolis-based company recalled four products: Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators.
