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# Medtronic Defibrillator Recall is Class 1
- URL: https://www.fdaweb.com/medtronic-defibrillator-recall-is-class-1/
- Published: 2022-08-19T12:00:00.000Z
- Updated: 2026-09-14T17:56:38.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5152548

FDA has classified as Class 1 a recent Medtronic recall of its Cobalt/Crome implantable cardioverter defibrillators and resynchronization therapy defibrillators due to reports about devices with a short circuit protection alert resulting in reduced-energy electric shock delivery, instead of delivering a second phase of high voltage therapy. “A reduced-energy electrical shock may fail to correct an irregular heartbeat (arrythmia) or may cause an irregular heartbeat,” an FDA [recall notice](https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-cobalt-xt-cobalt-and-crome-icds-and-crt-ds-risk-devices-may-issue-short-circuit?ref=fdaweb.com) says. “The harms associated with a reduced-energy electric shock or an inaccurate response to an SCP alert may cause serious injury or death.” The agency says there have been 27 complaints, no injuries, and no deaths associated with the issue.

The devices are intended to monitor and regulate heart rate and rhythm. They can deliver a pacing impulse to correct a slow heartbeat (bradycardia), provide biventricular pacing/cardiac resynchronization therapy, or produce an electric shock (cardioversion or defibrillation) to restore a regular heartbeat if a life-threatening arrhythmia occurs.