FDA categorizes recall of ICDs, CRT-Ds as class I

The FDA announced it has identified a recall of certain implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators made by Medtronic as class I, the most serious kind.

According to an alert by the agency, Medtronic began the recall in January due to a defect in the devices’ manufacturing process which could lead to an error preventing electrical shock delivery.

The 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 reviving a patient in cardiac arrest, according to the alert.

The delay or inability to deliver a shock to a patient in cardiac arrest or to properly pace a heartbeat that is too slow could result in serious injury or death, the agency stated in the alert.

The recall concerns devices — including certain models and serial numbers of the Amplia, Claria, Compia and Viva families of CRT-Ds and the Evera and Visia families of ICDs — that were manufactured between July 13, 2013 and August 8, 2017. A total of 48 units have been recalled nationwide, according to the FDA.

The Medtronic recall notice asked health care providers treating patients with HF or arrhythmia disorders with the affected devices to:

Consider prophylactic device replacement for patients who have been implanted with one of the affected devices;

Contact their sales representative for terms and conditions for device warranties;

Review the recall notice and ensure appropriate staff is aware of it.

According to the release, Medtronic will offer a supplemental device warranty for affected devices.

Customers with questions should contract their Medtronic sales representatives or Medtronic Technical Services at 800-723-4636; patients with questions can call Medtronic Patient Services at 800-551-5544.