Recall Z-2624-2026— Medtronic Heart Valves Division
Class I · Ongoing
Class I FDA medical device recall by Medtronic Heart Valves Division, initiated 2026-05-22. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Medtronic Heart Valves Division
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2026-05-22
- Firm location
- Santa Ana, CA, United States
Product description
Medtronic Harmony Delivery Catheter System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.