The U.S. Food and Drug Administration has issued a recall alert on several Medtronic defibrillators for a problem that may result in serious injury or death.
The recall includes the Cobalt, Cobalt XT and Crome defibrillators, affecting nearly 88,000 devices. It is designated a Class 1 recall, a category reserved for the most severe issues.
Defibrillators are implantable devices that can deliver impulses to correct a slow heartbeat and can also generate an electric shock to restore a regular heartbeat in the event of arrhythmia, which can be life-threatening.
The Medtronic devices are being recalled due to the potential for delivering reduced, lower-than-necessary shocks. A software update can fix this problem and the company has already received FDA approval for the update.
The update has also been granted a CE mark, which clears it for use in the European Union.
Medtronic initiated a voluntary recall on June 22. To date, there have been 27 complaints related to the issue. And while a Class 1 recall is reserved for problems that could result in serious injury or death, there have been no reports of either related to this glitch.
In a statement, Medtronic said: "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."
The company previously advised doctors that adjusting the device settings could mitigate the issue.
Medtronic announces its first-quarter results Tuesday morning.
