Medtronic Harmony Delivery Catheter System

What happened?

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.

What should I do now?

1Check the lot number on your product packaging.
2If you have it, stop using it.
3Return it to your pharmacy or store for a refund.
4If you already used it and feel unwell, see your doctor immediately.
5Report adverse effects to the FDA: 1-800-FDA-1088.

Company: Medtronic Heart Valves Division
Status: Ongoing
Report date: 2026-07-08
Initiated: 2026-05-22
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.
Quantity: 1881 units

This is NOT medical advice. Consult with your pharmacist or doctor before making decisions.