Medtronic is recalling its Harmony Delivery Catheter, which is part of its Transcatheter Pulmonary Valve (TPV) system, due to a risk where the bond holding the capsule at the end of the delivery catheter may break during a procedure to place the TPV.
The U.S. FDA has identified this as a Class I recall, the most serious type of recall. The FDA says use of these devices may cause serious injuries or death.
Those who may be affected include healthcare personnel who plan to implant the Harmony TPV into patients with severe pulmonary regurgitation; and people who are candidates for valve replacement using the Harmony TPV system.
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.
Read the full article at TCTMD.