Z-1240-2022Class II

Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)

Name: Z-1240-2022 Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Creator: Cook Incorporated
Published: 2022-05-05
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2022-05-05 / Open, Classified

FDA source

Cook Incorporated began a recall of Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498) on 2022-05-05. FDA classified it as Class II and gives the reason as "The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1240-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-05
Posted: 2022-06-06
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)
Product code: KRD Device, Vascular, For Promoting Embolization
Reason for recall: The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
FDA 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 in commerce: 106,033
Distribution: Domestic distribution nationwide. Foreign distribution worldwide.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1240-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1240-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-06
Z-1241-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-06
Z-1242-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-06-15	2022-06-06

Product code KRD

K160219Class IIHilal Embolization MicroCoilsCook Incorporated / cleared 2016-08-03

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)