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

Recall Summary Medtronic is recalling certain lots of the Harmony Delivery Catheter System used to implant pulmonary valves. The distal tip of the catheter may detach during use, potentially requiring additional endovascular or surgical procedures to remove it. The recall affects patients who have received or may receive this device.

Recalling firm

Pulmonary Valve Catheter Delivery System

Reason

The distal tip in certain lots of the Medtronic Harmony Delivery Catheter System (DCS) may detach which can require endovascular retrieval or surgical intervention.

Category

medical device recall

Country

United States

Agency

FDA-MEDWATCH-RSS

Recall date

2026-07-13

Status

Ongoing

Official recall notice from FDA-MEDWATCH-RSS

Recall details on Nibble Recalls: https://trynibble.app/recalls/5564f9ae-15a9-4547-a715-06e050d0dd3b