Medtronic Recalls Harmony Delivery Catheters Due to Breakage Risk

Medtronic is recalling delivery catheters used with its Harmony transcatheter pulmonary valve (TPV) system due to the risk of the capsule breaking during use, the US Food and Drug Administration announced today. The agency identified this as a Class I recall, the most serious type.

The Harmony TPV system was approved in 2021 as the first nonsurgical heart valve to treat severe pulmonary regurgitation in children and adults with a native or surgically repaired right ventricular outflow tract (RVOT). Today’s recall affects only the catheter that is used to implant the Harmony valve, which the FDA says amounts to 665 total devices within the US. Medtronic has received six complaints, including one reported injury, as a result of breaking of the bond that holds the capsule at the end of the catheter. No deaths have been reported as a result of this issue.

Medtronic issued an Urgent Medical Device Recall notice about the catheters on April 6, 2022, and is advising physicians to pause new cases involving the Harmony TPV system. Because the reported incidents of the catheter breaking only occurred during delivery of the valve, no actions are necessary in patients who have undergone successful implantation.