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Medtronic Heart Valves Division recalls Medtronic Harmony Delivery Catheter System
Recalled July 8, 2026 · FDA recall Z-2624-2026 · Medtronic Heart Valves Division
Hazard
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. · FDA Class I
Units
1881 units
Sold at
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, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Description
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.
Product
Medtronic Harmony Delivery Catheter System
Manufacturer(s)
Medtronic Heart Valves Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →