October 9, 2019 — Medtronic is recalling the 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 the 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.
Medtronic received five customer complaints, but no serious injuries or deaths were reported. However, the U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall.
The vendor said this recall does not affect the Medtronic Launcher Coronary Guide Catheter or other Medtronic coronary stents, balloons or implantable devices.
Recalled product includes all models of 6 French Sherpa NX Active Guide Catheters manufactured between March 10, 2017 to March 14, 2019. These were distributed between April 3, 2017 to April 4, 2019. The recall includes 106,298 devices in the U.S.
The Sherpa NX is used to access veins and arteries inside and outside of the heart (coronary and peripheral vascular systems). It may be used to assist with the placement and exchange of guidewires and other interventional devices and administer drugs or fluids into blood vessels. The primary users of this device are physicians.
On June 15, 2019, Medtronic sent a revised urgent medical device recall notice to customers instructing them to tdentify and remove any affected catheters from inventory
Return any affected product(s) to Medtronic. Medtronic customer service can be contacted at 1-888-283-7868 to initiate a product return. The local Medtronic representative can assist customers in the return of this product and in determining appropriate alternative products.
Customers can complete the customer confirmation certificate and email to [email protected]