In a notice published by the FDA, the agency said Medtronic’s recall involves removing certain devices from where they are used or sold. The FDA identified it as the most serious type, as it could cause serious injury or death with continued use.
Harmony is Medtronic’s transcatheter pulmonary valve (TPV) offering. It first received FDA clearance in March 2021. However, an FDA Class I recall for the system in April 2022 saw it briefly leave the market. Medtronic relaunched Harmony in the U.S. in February 2023.
The valve treats patients with severe pulmonary regurgitation who have a native or surgically repaired right ventricular outflow tract. Harmony DCS, a single-use, intravascular, over-the-wire catheter incorporates a loading system. It facilitates the placement of Harmony TPV within a patient’s anatomy.
According to the FDA, Medtronic issued a letter to affected customers on May 28 outlining issues with certain valves of the Harmony DCS. Certain systems used for insertion have an increased risk of distal tip detachment.
Distal tip detachment during an implant procedure requires a secondary intervention to remove the tip, either by endovascular retrieval or surgical intervention. Additional potential risks include prolonged procedure time, extended fluoroscopy time, occlusion, tissue damage, pulmonary regurgitation, embolism, and hemorrhage. The issue does not involve the Harmony TPV.
Medtronic reports no serious injuries or deaths associated with the issue as of May 14, 2026. It told affected customers to immediately quarantine and return affected products. Patients already successfully implanted with Harmony need no additional action.
