Tip Detachment Risk Puts Medtronic Harmony Valve Catheter Lots in Class I Recall

The FDA has identified Medtronic's removal of certain lots of its Harmony Delivery Catheter System as a Class I recall, the agency's most serious category, because the catheter's distal tip may detach during the procedure to implant the Harmony transcatheter pulmonary valve.

The agency's recall notice, dated Monday, says the device may cause serious injury or death if use continues. It states that the issue does not involve the Harmony valve and that no additional actions are required for patients with a successfully implanted valve. As of May 14, 2026, Medtronic had not reported any serious injuries or deaths associated with the issue, according to the notice.

The tip detachment issue

Medtronic stated that certain lots of the catheter system have an increased risk of distal tip detachment. If the tip detaches during implantation, a second intervention is needed to remove it, either by endovascular retrieval or surgery. The FDA notice lists other potential risks including prolonged procedure time, extended fluoroscopy time, occlusion, tissue damage, pulmonary regurgitation, embolism and hemorrhage.

The FDA's recall database entry, recall number Z-2624-2026, gives the manufacturer's reason as inner shaft assemblies from specific manufacturing lots that may have an increased potential for tip detachment under certain procedural or anatomical conditions. The FDA-determined cause is listed as process control. The entry shows Medtronic initiated the action on May 22, 2026, with 1,881 units in commerce distributed across the US and more than 30 other countries and territories, including Canada, Japan, the UK and much of Europe.

The Harmony system is a single-use, over-the-wire delivery catheter used in a catheterization lab. The valve is indicated for children and adults with severe pulmonary regurgitation who have a native or surgically repaired right ventricular outflow tract and are clinically indicated for surgical pulmonary valve replacement, according to the FDA.

Instructions and earlier recall

Medtronic sent customers a letter on May 28 asking them to quarantine and return affected products, and to share the notice with implanters and any facility that received the devices. A Medtronic spokesperson told MedTech Dive that the problem is limited to certain delivery systems and that the company has resolved the underlying manufacturing problem, so future shipments will not be affected.

It is the second recall of the Harmony delivery system. In a 2023 release announcing the system's relaunch, Medtronic said it had initiated a voluntary recall of the delivery catheter system in March 2022 after six reported cases in which the bond holding the capsule at the end of the catheter broke, and that it had worked with the FDA to return the device to market.

Customers with questions were directed to Medtronic at (800) 854-3570.