FDA Flags Medtronic Pulmonary Valve Delivery System Recall as Class I Over Risk of Catheter Tip Detachment
The U.S. Food and Drug Administration (FDA) has announced a Class I recall, its most serious recall category, for certain Medtronic Harmony™ Delivery Catheter Systems (DCS) used to implant transcatheter pulmonary valves. The recall follows concerns that a manufacturing defect could cause the catheter's distal tip to detach during implantation, potentially leading to serious complications, including emergency surgery or death.






















