There have been six reports of delivery catheter capsule breakage during procedures, including one injury.
Medtronic is recalling delivery catheters used with its Harmony transcatheter pulmonary valve (TPV) system due to the risk of capsule rupture during use, the U.S. Food and Drug Administration announcement today. The agency identified this as a Class I recall, the most severe type.
The Harmony TPV System was approved in 2021 as the first non-surgical 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 only affects the catheter used to implant the Harmony Valve, which the FDA says equates to 665 total devices in the United States. Medtronic has received six complaints, including one reported injury, following the rupture of the bond that secures the capsule to the tip of the catheter. No fatalities have been reported as a result of this issue.
Medtronic issued an Urgent Medical Device Recall Notice for Catheters on April 6, 2022 advising physicians to suspend new cases involving the Harmony TPV System. Since reported incidents of catheter rupture have only occurred during valve placement, no action is required in patients who have undergone successful implantation.