Cook Ireland Recalls Zilver Vascular Stents Due to Sizing Error
Cook Ireland is recalling 15 Zilver 518 Vascular Self Expanding Stents because a unit was found to be the wrong size, causing it to lodge in a sheath.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk-of-harm product (vascular stent) where a mechanical failure (lodging) occurred, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Cook Ireland Ltd. is recalling 15 units of the Zilver 518 Vascular Self Expanding Stent (Part Order Number: ZIV5-18-125-8-80, Lot Number: CF694429). The recall was initiated after a product complaint received from Japan on December 22, 2011, reported that a 5 French stent from this lot became lodged in a sheath hub during insertion. Subsequent examination revealed that the product was actually a 6 French Zilver Vascular Stent (Part Number: ZIV6-35), indicating a sizing discrepancy.
The affected stents are intended for use as an adjunct to percutaneous transluminal angioplasty in the treatment of symptomatic disease of iliac arteries. The distribution pattern for this lot includes the United States (nationwide) and Japan. The expiration date for the affected units is 09-2014.
Healthcare providers and patients should stop using the affected stents and contact Cook Ireland Ltd. for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- 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.…
- Manufacturer
- Cook Ireland Ltd.
- Category
- Medical Device — Vascular Stent
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Part order number: ZIV5-18-125-8-80
- Lot Number: CF694429
- Expiration Date: 09-2014
Distribution
Distributed nationwide across the United States.
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