FDA: Class I recall of Medtronic’s 6 French Sherpa NX Active Guide Catheters

Editor's Note

The Food & Drug Administration (FDA) on October 8 announced the recall by Medtronic of all models of its 6 French Sherpa NX Active Guide Catheters.

Medtronic is recalling the catheters because of the risk of the outer material separating from the device, resulting in detached fragments that could expose the underlying stainless-steel braid wires. These fragments could remain in the patient’s bloodstream, and attempts to retrieve them could result in blockage of blood vessels, injury to blood vessel walls, development of blood clots, embolism, heart attack, or death.

The catheters are used with placement and exchange of guidewires and other interventional devices.

Distribution dates are April 3, 2017 to April 4, 2019.