FDA Medical Device Recalls (openFDA)
Cook Incorporated: Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
- Recall number
- Z-1240-2022
- Recalling firm
- Cook Incorporated
- Product
- Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
- Status
- Open, Classified
- Initiated
- 2022-05-05
- Posted
- not on file
- Terminated
- not on file
- Reason
- The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
- Root cause
- Under Investigation by firm
- Action
- On May 5, 2022, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were advised that the presence of a small stainless steel cannula inside the loading cartridge may go undetected by the user. Customers were instructed to examine their inventory and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. Customers should return the product to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Please share this information with appropriate personnel, down to the user level, within your organization or with any organization where the affected devices may have been transferred. Physicians should practice their standard patient monitoring following the procedure for an early identification of any complications to mitigate their severity. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
- Quantity
- 106,033
- Distribution
- Domestic distribution nationwide. Foreign distribution worldwide.
- Lot, serial or model codes
- Lots: 14212811 14215685 14212247 14212812 14212814 14215682 14361413 14361416 14285326 14285328 14285330 14297289 14361412 14445407 14444454 14477949 14477950 UDI: (01)00827002474994(17)261013(10)14212811 (01)00827002474994(17)261008(10)14215685 (01)00827002474987(17)261011(10)14212247 (01)00827002474987(17)261008(10)14212812 (01)00827002474994(17)261008(10)14212814 (01)00827002474994(17)261008(10)14215682 (01)00827002474994(17)261219(10)14361413 (01)00827002474994(17)261220(10)14361416 (01)00827002474987(17)261110(10)14285326 (01)00827002474987(17)261110(10)14285328 (01)00827002474994(17)261110(10)14285330 (01)00827002474994(17)261123(10)14297289 (01)00827002474987(17)261220(10)14361412 (01)00827002474987(17)270207(10)14445407 (01)00827002474994(17)270207(10)14444454 (01)00827002474987(17)270217(10)14477949 (01)00827002474994(17)270216(10)14477950
- 510(k) numbers
- ["K160219"]
- PMA numbers
- not on file
- Product code
- KRD
- 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