The U.S. Food and Drug Administration issued its most serious type of recall for 348,616 Medtronic defibrillators, saying they are at risk for delivering "a reduced-energy shock or not shock at all," which could lead to cardiac arrest for a patient.
The Class I recall includes Medtronic implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators, with a glassed feedthrough, manufactured after 2017. The defibrillators recalled are sold under a number of different brand names including Cobalt, Claria, Amplia, Viva, Brava and Visia.
The FDA issues a Class I recall when the use of a device may cause serious injuries or death.
