Medtronic Heart Valves Division: Pulmonary Valve Prosthesis Percutaneously Delivered
Recall Summary Medtronic is recalling Harmony Delivery Catheter Systems used to implant pulmonary valve prostheses because certain manufacturing lots may have a defect in the inner shaft assembly that could cause the distal tip to separate from the delivery system during the procedure. The recall affects devices distributed worldwide, including throughout the United States and 34 other countries. Patients who have received this device or those scheduled to receive it should contact their healthcare provider.
- Recalling firm
- Medtronic Heart Valves Division
- Product
- Medtronic Harmony Delivery Catheter System
- Reason
- Devices containing inner shaft assemblies from specific manufacturing lots may have an increased potential for distal tip detachment from the delivery system under certain procedural or anatomical conditions due to a manufacturing issue.
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-22
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Austria, Canada, Chile, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Jordan, Mexico, Netherlands, Northern Ireland, Norway, Oman, Poland, Portugal, Puerto Rico, Qatar,...
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/24e9ca6e-ac46-4763-ac64-b0b7b7c83271