Class 1 Recall for Sherpa NX Active Guide Catheter

Patrice Wendling

October 09, 2019

Medtronic is recalling its 6-French Sherpa NX Active Guide catheter because the outer material may separate from the device, resulting in the detachment of fragments and exposure of stainless-steel braid wires, according to the company.

The US Food and Drug Administration (FDA) has identified this as a class 1 recall, the most serious kind, because of the potential for serious injuries or death.

"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," the agency writes.

The catheter is used to access the coronary or peripheral vascular systems and is the conduit for device placement and exchange of guide wires and for drug or fluid administration.

Medtronic notified customers on March 15, 2019, of the defect and that affected devices should be quarantined and/or returned. A June 15, 2019 revised urgent medical device recall notice further advised customers to identify and remove any affected catheters from inventory.

The recall involves 106,298 devices in the United States and includes all models of the 6-F Sherpa NX Active Guide catheter. The affected devices were manufactured between March 10, 2017, and March 14, 2019, and were distributed from April 3, 2017, to April 4, 2019.

Medtronic has received five customer complaints but no reports of serious injuries or death, according to the FDA.

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