Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is… — Class II medical device recall Z-2309-2012

Terminated recall by Cook Ireland Ltd., reported 2012-09-12, distributed nationwide. Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a 5

Recall number	`Z-2309-2012`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Cook Ireland Ltd., Limerick, Peroc, N/A, Ireland
Recall initiated	2012-01-05
Classified	2012-08-31
Reported by FDA	2012-09-12
Terminated	2013-02-04
Distributed	Nationwide (US)
Countries outside the US	JP
Lot numbers	`CF694429`
Expiration dates	`2014-09`

Product

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.

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2309-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.