Medtronic recalls cardiac resynchronization therapy and implantable cardioverter defibrillators due to manufacturing error. Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are devices that provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms.
ICDs and CRT-Ds are both implanted under the skin in the upper chest area with connecting insulated wires called "leads" that go into the heart. Patients need an ICD or CRT-D if their heartbeat is too slow (bradycardia), too fast (tachycardia), or needs coordination to treat heart failure.
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.
Medtronic is recalling certain ICDs and CRT-Ds due to a defect in the manufacturing process. This defect causes an out of specification gas mixture inside the device and may prevent the device from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest.
A total of nine CRT-Ds and 12 ICD models were included in the recall. On January 22 2018 Medtronic sent an Urgent Medical Device Recall notice to affected customers.
Medtronic also directed care providers to consider replacing the affected ICDs – which include Evera and Visia models – with prophylactic devices.
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