FDA Medical Device Recalls (openFDA)
Wilson-Cook Medical Inc: Za-Stent Expandable Metal Biliary Stent
- Recall number
- Z-1180-03
- Recalling firm
- Wilson-Cook Medical Inc
- Product
- Za-Stent Expandable Metal Biliary Stent
- Status
- Terminated
- Initiated
- 2002-01-08
- Posted
- 2003-08-26
- Terminated
- 2005-03-21
- Reason
- The inner catheter of the introducer system may break after stent deployment.
- 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
- 12 units
- Distribution
- The product was distributed to hospitals located nationwide and worldwide.
- Lot, serial or model codes
- Reorder #ZABS-10-8-C, Amended 8/8/2003 to include: ZABS-10-4-C, ZABS-10-6-C
- 510(k) numbers
- ["K941350"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 1037905
- Firm city
- Winston-Salem
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28