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Cook Medical Incorporated recalls Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Recalled February 3, 2016 · FDA recall Z-0689-2016 · Cook Medical Incorporated
Hazard
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 · FDA Class II
Units
753
Sold at
Nationwide Worldwide
Description
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
Product
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Manufacturer(s)
Cook Medical Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →