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

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.

Recommended Action

Per FDA guidance

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.