Z-1181-03

Zilver Expandable Metal Biliary Stent

Name: Z-1181-03 Zilver Expandable Metal Biliary Stent
Creator: Wilson-Cook Medical Inc
Published: 2002-01-08
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2002-01-08 / Terminated

FDA source

Wilson-Cook Medical Inc began a recall of Zilver Expandable Metal Biliary Stent on 2002-01-08. The reason FDA records is "The inner catheter of the introducer system may break after stent deployment". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1181-03
Status: Terminated
Initiated: 2002-01-08
Posted: 2003-08-26
Terminated: 2005-03-21
Recalling firm: Wilson-Cook Medical Inc.
Product: Zilver Expandable Metal Biliary Stent
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: The inner catheter of the introducer system may break after stent deployment.
FDA root cause: Other
Action: Initially the firm conducted a Market Withdrawal on January 8, 2002. Subsequently the firm initiated a recall, notifying consignees via letter on 8/8/2003. A Customer Response Form was attached.
Quantity in commerce: 57 units
Distribution: The product was distributed to hospitals located nationwide and worldwide.
Product codes and lots: Reorder #ZILBS-6-6 ZILBS-10-8, ZILBS10-6, Amended 8/8/2003 to include: ZILBS-10-4, ZILBS-8-4, ZILBS-8-6, ZILBS-8-8, ZILBS6-4, ZILBS-6-8

Product code FGE

K020788Class IIWilson-Cook Zilver Biliary StentWilson-Cook Medical, Inc. / cleared 2002-05-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)