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Pulmonary Valve Catheter Delivery System Recall: Medtronic Removes Harmony Delivery Catheter System (DCS)
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.
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. Detachment of the distal tip during the implant procedure will require a secondary intervention to remove the tip, either by endovascular retrieval or surgical intervention. Additional potential patient risks associated with this issue may include prolonged procedure time, extended fluoroscopy time, occlusion, tissue damage, pulmonary regurgitation, embolism, and hemorrhage. This issue does not involve the Harmony TPV.
As of May 14, 2026, Medtronic has not reported any serious injuries or deaths associated with this issue.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it.
Questions?
Customers in the U.S. with questions about this recall should contact Medtronic at rs.structuralheartfieldassurance@medtronic.com or (800) 854-3570.
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