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

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.Affected Product 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.Affected devices:Device Descriptive NameModel NameUDI-DIHarmony Delivery Catheter SystemHARMONY-DCS00763000341367Harmony Delivery Catheter SystemHARMONY-DCS00763000544027Harmony Delivery Catheter SystemHARMONY-DCS00763000520151Harmony Delivery Catheter SystemHARMONY-DCS00763000582951Harmony Delivery Catheter SystemHARMONY-DCS00763000918712Full List of Affected Device Lot NumbersWhat to DoDo not use affected products.

No additional actions are required for patients with a successfully implanted Harmony TPV.On May 28, 2026, Medtronic sent all affected customers a letter recommending the following actions:Immediately quarantine and return the affected products to Medtronic.Share the Medtronic notification with implanters of the affected products within your organization and their teams. If any of the affected products have been forwarded from your facility to another facility, please notify the other facility about the Medtronic notification.Because the potential tip detachment is limited to the Harmony DCS during delivery of the Harmony TPV, there are no additional actions required for patients with a successfully implanted Harmony TPV. These patients should continue to be monitored according to each practice’s standard clinical follow-up procedures.Reason for RecallMedtronic 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.Device UseThe Harmony DCS is a single use, intravascular, over-the-wire delivery catheter incorporating a loading system.

It is used in a catheterization lab to facilitate placement of the Harmony TPV within a patient's anatomy. The Harmony TPV System is indicated for use in the management of pediatric and adult patients with severe pulmonary regurgitation who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement.Contact InformationCustomers in the U.S. with adverse reactions, quality problems, or questions about this issue should contact Medtronic at rs.structuralheartfieldassurance@medtronic.com or (800) 854-3570.Additional FDA ResourcesFDA Enforcement ReportCDRH Medical Device Recall DatabaseUnique Device Identifier (UDI)The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use.

The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.How do I recognize a UDI on a label?AccessGUDID database - Identify Your Medical DeviceBenefits of a UDI SystemHow do I report a problem?Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.