FDA: Class I recall of certain Medtronic ICDs, CRT-Ds

Editor's Note

The Food & Drug Administration (FDA) on February 27 classified the recall by Medtronic of certain Implantable Cardiovert Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) as Class I, the most serious.

The recall was initiated because of a defect in the manufacturing process. The defect causes an out of specification gas mixture inside the device that may prevent it from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest. Manufacturing dates for the devices are July 13, 2013 to August 8, 2017.

Delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient's heart whose heartbeat is too slow could result in serious injury and/or death.

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