FDAFDA · Food and drugs·Recall number Z-2309-2012
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.
Published September 12, 2012 · Recall initiated: January 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Cook Ireland Ltd.
- Distributor
- Worldwide distribution: USA (nationwide) and country of: Japan.
- Lot
- Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Ireland
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