FDA Medical Device Recalls (openFDA)
Cook, Inc.: Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.
- Recall number
- Z-2057-2008
- Recalling firm
- Cook, Inc.
- Product
- Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.
- Status
- Terminated
- Initiated
- 2008-05-08
- Posted
- 2008-09-16
- Terminated
- 2008-10-21
- Reason
- The product length is declared incorrectly in mm when the unit of measurement should be cm.
- Root cause
- Labeling Change Control
- Action
- Consignees were notified via recall letter dated 5/9/08 that the firm would replace product on hand. Distributors were requested to notify their customers of the recall. If you have questions, contact Customer Relations Department at 800-346-2686.
- Quantity
- 1183
- Distribution
- Nationwide, Australia, Brazil, Canada, Columbia, Hong Kong, India, Israel, Korea, Malaysia, Panama, Peru, Singapore, Taiwan, Uruguay and Venezuela.
- Lot, serial or model codes
- Lots 1897765, 1902927, 1908780, 1910237, 1918237, 1921667, 1929329, 1934204, 1971324, 1971325, 1987735, 1991576, 1994124, 2000417, 2007745, 2012753x, 2012753, 2021721, 2026715, 2031205, 2034254, 2039748, 2051785, 2063422, 2066776, 2072751 and 2080653.
- 510(k) numbers
- ["K901337"]
- PMA numbers
- not on file
- Product code
- HCG
- 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