Cook Medical Incorporated recalls Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System

Recall date

December 22, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0689-2016

FDA classification

Class II

Brand / firm

Cook Medical Incorporated

Sold / distributed

Nationwide Worldwide

Why it was recalled

Manufacturing of the joint between the inner catheter and stylet of the delivery system does not consistently meet specifications, and the joint may separate during deployment. Failure of this joint during a procedure may result in a partial stent deployment. The clinical effect of a partial deployment may be a need for surgical intervention, or may result in vessel trauma or an embolic event

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System