FDA Medical Device Recalls (openFDA)
Cook, Inc.: Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-4.0-40.
- Recall number
- Z-0080-2007
- Recalling firm
- Cook, Inc.
- Product
- Cook Zilver 635 Biliary Stent - Expanding Stent, delivery system length 80 cm, stent diameter 8.0 mm, stent length 40 mm, minimum guiding catheter 8.0 French, minimum sheath 6.0 French, recommended wire guide size .035 inch dia., sterile; Catalog # ZIB6-80-4.0-40.
- Status
- Terminated
- Initiated
- 2006-09-21
- Posted
- 2006-10-28
- Terminated
- 2007-04-04
- Reason
- The side of the boxes give incorrect sizes for these stents. The label front is correct. (side label-5x40-front label-8x40)
- Root cause
- Other
- Action
- Consignees were notified via telephone on 9/21/06 and requested to return the recalled product.
- Quantity
- 5
- Distribution
- Class II Recall - Worldwide distribution ---- USA including the states of Idaho and Indiana, as well as, the country of Canada
- Lot, serial or model codes
- Lot 1722922.
- 510(k) numbers
- ["K051124"]
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- 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