FDA: Class I recall of Medtronic Cobalt/Crome ICDs, CRT-Ds

Editor's Note

The Food and Drug Administration (FDA) on August 19 identified the recall by Medtronic of its Cobalt XT, Cobalt, and Crome Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as Class I, the most serious.

The devices are being recalled because of reports of short circuit-protection alerts resulting in reduced-energy electric shock delivery, instead of delivering a second phase of high voltage therapy. A reduced shock may fail to correct an arrhythmia or cause an irregular heartbeat, which may result in serious injury or death.

Medtronic has received FDA approval and CE Mark for a software update to help mitigate this issue. The company began deploying the update into already-implanted Cobalt XT, Cobalt, and Crome devices via in-clinic device checks in mid-August 2022. Newly manufactured devices will have the update pre-installed starting this month.

There have been 27 complaints, no injuries, and no deaths reported. Distribution dates were February 3, 2020, to present.