Medtronic issued a Class 1 recall for its 6F Sherpa NX active guide catheter, used to access veins and arteries in the coronary and peripheral vascular systems.
The FDA said the company is recalling the product because of the risk of the outer material separating from the device and exposing the stainless-steel braid wires inside.
The fragments “could be left inside the patient’s bloodstream, and this or the attempts made to retrieve the fractured pieces, can cause other serious adverse health consequences such as continued blockage of blood vessels, injury to blood vessel walls, development of blood clots, embolism, heart attack or death,” the agency said.
