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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 61451

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
January 05, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cook Ireland Ltd.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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.

Z-2309-2012
Recall number
Z-2309-2012
Initiated
January 05, 2012
Classification
Class II
Status
Terminated
Recalling firm
Cook Ireland Ltd.
Quantity
15 units of ZIV5-18-125-8-80 LOT# CF694429

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

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Inspect official wording and provenance

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

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.

Field note

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