FDA-Device2016-02-03Class II
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
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
Sold states
Nationwide Worldwide
Affected count
753
Manufactured in
400 N Daniels Way, N/A, Bloomington, IN, United States
Products
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0689-2016Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief