The US Food and Drug Administration has classified Medtronic's removal of selected Harmony Delivery Catheter System devices as a Class I recall because of a manufacturing issue affecting specific catheter systems.
According to the FDA, a manufacturing issue involving inner shaft assemblies in selected production lots can increase the likelihood of distal tip detachment under certain procedural or anatomic conditions. The recall affects 1,881 devices distributed in the US and internationally.
The Harmony Delivery Catheter System is a single-use, over-the-wire delivery catheter that facilitates placement of the Harmony transcatheter pulmonary valve. The Harmony transcatheter pulmonary valve system is used in pediatric and adult patients with severe pulmonary regurgitation who have a native or repaired right ventricular outflow tract and are candidates for surgical pulmonary valve replacement.
The FDA stated that distal tip detachment during implantation may require a secondary intervention to remove the detached tip through endovascular retrieval or surgical intervention. Additional potential risks include prolonged procedure time, extended fluoroscopy time, occlusion, tissue damage, pulmonary regurgitation, embolism, and hemorrhage.
According to the FDA, the recall is limited to the delivery catheter and does not affect the implanted valve. The agency advised that patients with a successfully implanted Harmony transcatheter pulmonary valve do not require additional measures related to the recall and should continue with their usual follow-up care.
On May 28, 2026, Medtronic instructed customers to quarantine and return affected devices, share the recall notification with implanters, their teams, and any facilities that received redistributed products, and complete a customer confirmation form.
As of May 14, 2026, Medtronic reported no serious injuries or deaths associated with the issue.