Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)

Published: 07/13/2026

Sources:
  • Food and Drug Administration
Relevant To:
  • Rural Emergency Hospitals,
  • Medical Office,
  • Critical Access Hospitals,
  • Hospitals

The FDA is aware that Medtronic has issued a letter to affected customers recommending certain lots of the Harmony Delivery Catheter System (DCS) used for insertion of the Medtronic Harmony transcatheter pulmonary valve (TPV) be removed from where they are used or sold.

Full List of Affected Device Lot Numbers

Medtronic stated that certain lots of the Harmony DCS used for insertion of the Medtronic Harmony TPV have an increased risk of distal tip detachment. 

What to Do

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