FDA Medical Device Recalls (openFDA)
Cook, Inc.: Cook Hilal Embolization Microcoil, 6 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral arteriovenous malformations.
- Recall number
- Z-2058-2008
- Recalling firm
- Cook, Inc.
- Product
- Cook Hilal Embolization Microcoil, 6 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
- 180
- 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 F2100451, F2102327, F2102038, F2102833, F2109137, F2112851, F21114679, F2122527, F2125284, F2126416, F2136920, F2141567, F2142403, F2142578, F2143038, F2146823, F2146882, F2147969, F2150692, F2159335, F2159263, F2161387, F2172446, F2188499, F2189353, F2203609, F2204861, F2207480, F2213136, F2213468 and F2215748..
- 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