Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent Recalled by Cook Ireland Ltd. Due to Cook Ireland received a product complaint from Japan...
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 Ireland Ltd. directly.
Affected Products
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.
Quantity: 15 units of ZIV5-18-125-8-80 LOT# CF694429
Why Was This Recalled?
Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub. After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cook Ireland Ltd.
Cook Ireland Ltd. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report