CLASS II Device recall · Reported 12 Sep 2012 · FDA Enforcement Report
Zilver 518 Vascular Self Expanding Stent The Zilver recalled
Cook Irel is recalling Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use as, distributed nationwide in the US. The recall was initiated on 5 Jan 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2309-2012
- FDA event ID
- 61451
- Recalling firm
- Cook Irel, Limerick, Peroc, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jan 2012
- FDA classified
- 31 Aug 2012
- Reported
- 12 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Other
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 5 Jan 2012 | Recall initiated by company | |
| 31 Aug 2012 | Classified by FDA | +239 days |
| 12 Sep 2012 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution: USA (nationwide) and country of: Japan.
Questions about this recall
Why was it recalled?
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
Which lots are affected?
Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014
Where was it sold?
Worldwide distribution: USA (nationwide) and country of: Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Heart & Vascular Devices recalls
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| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |