FDA class 1 recall of medical device: the most serious type of recall

Medtronic is recalling Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Resynchronization Therapy Defibrillators (CRT-Ds) after receiving reports of devices with a short circuit protection (SCP) 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. The harms associated with a reduced-energy electric shock or an inaccurate response to an SCP alert may cause serious injury or death.

There have been 27 complaints, no injuries, and no deaths associated with this issue.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Medtronic Cobalt/Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are implantable cardiac devices that are intended to monitor and regulate heart rate and rhythm.

These devices 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.

FDA newsletter: 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?utm_source=CDRHTwitterD