Cook Ireland Ltd.: Medical Device Recall in 2012 - (Recall #: Z-2309-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 5, 2012

Date Posted: September 12, 2012

Recall Number: Z-2309-2012

Event ID: 61451

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

Status: Terminated

Product Quantity: 15 units of ZIV5-18-125-8-80 LOT# CF694429

Code Information:

Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014

Distribution Pattern:

Worldwide distribution: USA (nationwide) and country of: Japan.

Voluntary or Mandated:

Voluntary: Firm initiated