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Medtronic Heart Valves Division recalls
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Medtronic Heart Valves Division and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-08FDA-DeviceClass IMedtronic Harmony catheter recalled for tip detachment risk
Certain lots of the Medtronic Harmony Delivery Catheter System may have a manufacturing defect that increases the risk of the distal tip detaching from the delivery system during use. This could occur under specific procedural or anatomical conditions. About 1,881 units worldwide are affected.
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