Z-2057-2008

Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to...

Name: Z-2057-2008 Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to...
Creator: Cook, Inc.
Published: 2008-05-08
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2008-05-08 / Terminated / root cause: labeling and UDI

FDA source

Cook, Inc. began a recall of Cook Hilal Embolization Microcoil, 3 mm, sterile. The device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and... on 2008-05-08. The reason FDA records is "The product length is declared incorrectly in mm when the unit of measurement should be cm". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2057-2008
Status: Terminated
Initiated: 2008-05-08
Posted: 2008-09-16
Terminated: 2008-10-21
Recalling firm: Cook Incorporated
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.
Product code: HCG Device, Neurovascular Embolization
Reason for recall: The product length is declared incorrectly in mm when the unit of measurement should be cm.
Root cause tag: labeling and UDI
FDA 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 in commerce: 1183
Distribution: Nationwide, Australia, Brazil, Canada, Columbia, Hong Kong, India, Israel, Korea, Malaysia, Panama, Peru, Singapore, Taiwan, Uruguay and Venezuela.
Product codes and lots: 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.

Product code HCG

K901337Class IIHilal Embolization Microcoil(tm)Cook, Inc. / cleared 1990-11-13

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)