Medtronic Recalls 350,000 Heart Devices after 22 Injuries, FDA Reports

Medtronic, the global medical technology company, is recalling nearly 350,000 implantable cardiac devices. 

This recall follows continuous issues with their ability to deliver high-voltage therapy when necessary, according to the U.S. Food and Drug Administration (FDA).

Scope of the Recall

The recall involves all implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a glassed feedthrough manufactured after 2017. The FDA has categorised this as a Class I recall. This means that using these devices “may cause serious injuries or death”.

Among the specific products recalled are the Cobalt XT, Cobalt and Crome ICDs and CRT-Ds; Claria MRI, Amplia MRI, Compia MRI, Viva and Brava CRT-Ds; and Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, and Mirro MRI ICDs. 

This ongoing issue has led to 28 incidents and 22 injuries. Fortunately, no deaths have been reported. Previously in August 2022, a similar problem forced Medtronic to recall 87,709 devices.

The Danger of Reduced-Energy Shock

Doctors use implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) mainly to treat life-threatening arrhythmias, which are serious heart rhythm problems. These devices deliver high-voltage shocks to the heart to correct abnormal heart rhythms, especially those that can cause cardiac arrest.

If the energy shock from these devices does not work properly or fails to deliver a shock when needed, it can result in a variety of serious health risks.

A reduced-energy shock, or lack thereof, could fail to correct a life-threatening arrhythmia. This failure could lead to cardiac arrest, other serious injuries, or even death, as per an advisory on the FDA website. Additional risks are present if a patient needs further surgical procedures to remove and replace the device.

Response from Medtronic

On May 10, Medtronic sent an Urgent Medical Device Correction Notice to all affected customers with detailed instructions. Customers were warned against prophylactically replacing devices and advised to program “all high-voltage therapy pathways B>AX in all therapy zones.” Medtronic stressed the need for follow-up care for patients with AX>B programming in any high-voltage therapy sequences so that necessary reprogramming can occur.

Medtronic has a presence in Asia, with its Asia Pacific headquarters in Singapore. As of publishing, there has not been a recall in the Asian region yet.