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.
FDA issues recall alert for some Medtronic defibrillators
The federal agency deemed the problem serious, but so far no injuries or deaths associated with it have been reported. The problem can be fixed with a software update.
August 22, 2022 at 5:15PM
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.
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