FDA-Device2026-07-08Class I
Medtronic Harmony Delivery Catheter System
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.
Sold states
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.
Affected count
1881 units
Manufactured in
1851 E Deere Ave, N/A, Santa Ana, CA, United States
Products
Medtronic Harmony Delivery Catheter System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2624-2026Don't want to check this manually?
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