Z-2309-2012Class II

Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to...

Name: Z-2309-2012 Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to...
Creator: Cook Ireland Ltd.
Published: 2012-01-05
License: https://open.fda.gov/license/

Cook Ireland Ltd. / initiated 2012-01-05 / Terminated / root cause: packaging

FDA source

Cook Ireland Ltd. began a recall of Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the... on 2012-01-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2309-2012
Classification: Class II
Status: Terminated
Initiated: 2012-01-05
Posted: 2012-09-01
Terminated: 2013-02-04
Recalling firm: Cook Ireland Ltd.
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.
Product code: NIO Stent, Iliac
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
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm, Cook Medical, sent a letter dated February 13, 2012 to foreign consignee. The letter described the product, problem and actions taken. The firm stated that re-training of the relevant personnel has been carried out; they will continue to monitor to identify potential emerging trends and further corrective and preventive action will be considered in an effort to avoid the recurrence of similar events. If you have any question contact in US: Customer Relations Manager at 800.346.2686.ext 2222 or email: [email protected]; OUS: Customer Quality Supervisor at +353 61 239343.
Quantity in commerce: 15 units of ZIV5-18-125-8-80 LOT# CF694429
Distribution: Worldwide distribution: USA (nationwide) and country of: Japan.
Product codes and lots: Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2309-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2309-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-12	2012-08-31

Product code NIO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)