Tag: pulmonary_valve

FDA Issues Class I Recall for Medtronic Harmony Delivery Catheter System

13 Jul 2026 3:19 p.m. · Source: US Food and Drug Administration

Medtronic's Harmony Delivery Catheter System faces a Class I recall by the FDA due to a risk of distal tip detachment. This serious issue could require secondary intervention and poses significant patient risks, though no serious injuries or deaths are…

Health Business Politics and Government Medical Science Federal Government Legal Medtronic Harmony Delivery Catheter System Product Recall FDA Medical Device Class I Recall Pulmonary Valve Food Recalls Drugs