Critical Alert
Medtronic Heart Valves Division Recalls Medtronic Harmony Delivery Catheter System
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2624-2026Medical Device
Medtronic Heart Valves Division Recalls Medtronic Harmony Delivery Catheter System
Medtronic Heart Valves Division · Class I — Most Serious
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.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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, Romania, Saudi Arabia, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Medtronic Heart Valves Division is recalling a medical device classified as Class I by the FDA — the highest risk level. The recall was initiated on May 22, 2026 affecting 1881 units. 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. It was distributed internationally, including the United States. Consumers and healthcare professionals should exercise caution and discontinue use of the recalled product. Contact the recalling firm directly for return or disposal instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects.