Medtronic is recalling its Harmony Delivery Catheter System, which is part of the Harmony Transcatheter Pulmonary Valve (TPV) System due to the risk of breakage during placement of the TPV.
The Class I recall affects 665 devices in the United States. There have been six complaints and one injury related to this device issue, but no deaths have been reported.
Indicated for use in children and adults with severe pulmonary regurgitation, the TPV system is used to treat a leaky native or surgically repaired right ventricular outflow tract (the part of the heart that carries blood to the lungs). The catheter enables minimally invasive implantation of the replacement valve.
The FDA has advised that physicians and customers return all unused products to Medtronic and pause any new clinical cases that involve using the Harmony TPV System.