Medtronic recalls Harmony delivery catheter system after tip detachment risk

Medtronic has issued a recall of certain lots of its Harmony Delivery Catheter System (DCS), which is used to implant the Harmony transcatheter pulmonary valve.

The FDA classified the recall as the most serious type because the distal tip of the catheter can detach, potentially requiring endovascular retrieval or surgery and posing a risk of serious injury or death.

Medtronic sent a letter on May 28, 2026 advising customers to immediately quarantine and return the affected devices, and to inform all implanters. No further action is needed for patients who already have a successfully implanted Harmony TPV.