Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Recalled by Medtronic Inc Due to There is potential for the capsule bond to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Inc directly.
Affected Products
Harmony Delivery Catheter System. Part of the Harmony Transcatheter Pulmonary Valve (TPV) Replacement Implantation System.
Quantity: 1483 devices
Why Was This Recalled?
There is potential for the capsule bond to break during the procedure.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Medtronic Inc
Medtronic Inc has 17 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report