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.
Defibrillators monitor and regulate a patient’s heart rate and rhythm and deliver an electric shock when detecting a potentially life-threatening arrhythmia to restore a normal heartbeat.
Medtronic issued an Urgent Medical Device Correction Notice to customers about the defibrillators on May 10. The problem is a software issue that can be addressed by reprogramming.
“Medtronic provided physicians with comprehensive patient management recommendations. We have recommended that physicians non-invasively reprogram these devices to reduce the risk for this issue,” the company said in a statement.
Medical device recalls are often initiated by companies. It typically takes the FDA a few months to classify the severity of the recall. The FDA issued the notice about the defibrillators on Tuesday.
Medtronic reported 28 incidents, 22 injuries and no deaths with these devices.
The FDA issued a similar Class I recall last August for other Medtronic defibrillators.
Medtronic saw 23 Class I recalls in 2021 and 2022, an atypically high number for the company. In response the company added a more rigorous internal review process for analyzing the risk assessment of a device. In January, the company also hired Scott Cundy as its new chief quality officer, another step to address past recall issues.
Medtronic urged customers with concerns to contact Medtronic Technical Services at 1-800-929-4043.
