Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported September 12, 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.
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…
Compiled from official public sources by the editorial team.
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Cook Ireland Ltd. recalled Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use… - a moderate-severity action.
Zilver 518 Vascular Self Expanding Stent The Zilver Vascular Stent is intended for use… was recalled by Cook Ireland Ltd. in September 12, 2012. Reason: Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a…. Check the official notice for the remedy. Verify recall #Z-2309-2012 with the FDA Devices before acting.
The recall
Cook Ireland Ltd. issued this moderate-severity FDA Devices recall-Cook Ireland received a product complaint from Japan on December 22nd, 2011. The complainant reported that a….
- Moderate
- severity level
- 15 units
- affected scope
- Class II
- classification
- September 12, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2309-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2309-2012) was formally reported on September 12, 2012, with the manufacturer initiating the action on January 5, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Cook Ireland Ltd. is listed as the recalling firm, operating out of Limerick, Peroc, N/A. Federal records list the affected scope as 15 units of ZIV5-18-125-8-80 LOT# CF694429.
The documented reason for this recall is: 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 o… Distribution data in the federal record shows the product reached: Worldwide distribution: USA (nationwide) and country of: Japan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
15 units of ZIV5-18-125-8-80 LOT# CF694429
Related Recalls
6
3 from same agency
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.
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
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2309-2012 |
| Date reported | September 12, 2012 |
| Date initiated | January 5, 2012 |
| Recalling firm | Cook Ireland Ltd. |
| Firm location | Limerick, Peroc, N/A |
| Affected scope | 15 units of ZIV5-18-125-8-80 LOT# CF694429 |
| Distribution | Worldwide distribution: USA (nationwide) and country of: Japan. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2309-2012) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cook Ireland Ltd.. Units affected: 15 units of ZIV5-18-125-8-80 LOT# CF694429.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on September 12, 2012. Severity: Moderate. Recall number: Z-2309-2012.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA (nationwide) and country of: Japan..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2309-2012) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported September 12, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.