Class 1 Recall of Medtronic Guide Catheter

FDA has classified as Class 1 a Medtronic recall of its 6 French Sherpa NX Active Guide Catheter due to a risk of the outer material separating from the device resulting in detached fragments that could result in underlying stainless-steel braid wires being exposed. “These 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,” a recall notice says. The device is used to access veins and arteries inside and outside the heart (coronary and peripheral vascular systems). It may also be used to assist with the placement and exchange of guidewires and other interventional devices and administer drugs or fluids into blood vessels.