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Medical Device

Medtronic Harmony Delivery Catheter System

Recall date: 2026-07-08 · Source: FDA_DEVICE
Brand / Firm
Medtronic Heart Valves Division
Product
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.
Units affected
1881 units
Description
Medtronic Harmony Delivery Catheter System
View official recall notice →