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Medtronic is recalling all ICDs and CRT-Ds, manufactured after 2017, with a glassed feedthrough as they may deliver low or no energy output when needed for high voltage therapy.
Due to a risk of low or no energy output during high voltage therapy, Medtronic and the FDA announced a Class I recall of certain Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough.
The agency says affected devices may deliver a low-energy shock, or none at all, in patients who need it.
The FDA designated a recall of some Medtronic (NYSE: MDT) defibrillators as Class I, the most serious kind.
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.