Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System Recalled by Cook Medical Incorporated Due to Manufacturing of the joint between the inner catheter...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Cook Medical Incorporated directly.
Affected Products
Zilver¿ 518RX Vascular Stent with Rapid Exchange Delivery System
Quantity: 753
Why Was This 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
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cook Medical Incorporated
Cook Medical Incorporated has 53 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report