The US Food and Drug Administration (FDA) has declared a class I recall of a limited number of implantable defibrillators from Medtronic, including some with biventricular pacing capability, because of a manufacturing defect.
“This defect causes an out-of-specification gas mixture inside the device” that could cause it to fail to deliver high- or low-voltage therapy (that is, shocks or pacing), according to the agency.
The recall applies to 48 individual devices, listed by their serial numbers, that include Medtronic Evera and Visia implantable cardioverter-defibrillators (ICDs) and Amplia, Claria, Compia, and Viva cardiac resynchronization therapy-defibrillators (CRT-Ds).
On January 22, Medtronic instructed clinicians to “consider prophylactic device replacement for patients who have been implanted with one of the affected devices.”
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