FDA-Device2026-07-08Class IPROCESSING DEFECT
Medtronic Harmony Delivery Catheter System recalled for distal tip detachment risk
What this means
Certain lots of the Medtronic Harmony Delivery Catheter System may have a manufacturing defect that increases the risk of the distal tip detaching from the delivery system during use. This could occur under specific procedural or anatomical conditions. About 1,881 units worldwide are affected.
- Check if your device lot number matches the recalled lots listed in the FDA notice
- Contact Medtronic or your healthcare provider immediately if you have an affected device
- Do not use the device if it is confirmed to be from a recalled lot
- Follow guidance from your doctor or Medtronic regarding replacement or safe handling
The agency's original wording
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.
Intended for
Adults
Illnesses reported
None reported
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-2624-2026Want us to check the next one for you?
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