Recall Z-1241-2022 ยท KRD Device, Vascular, For Promoting Embolization
Cook Incorporated
Nester Embolization Microcoil RPN GPN MWCE-18-5-2-NESTER G52733 MWCE-18-5-3-NESTER G52734 MWCE-18-7-3-NESTER-01 G47338 MWCE-18-7-2-NESTER-01 G47337 MWCE-18-7-5-NESTER-01 G47340 MWCE-18-3-2-NESTER G52731 MWCE-18-7-8-NESTER-01 G47342 MWCE-18-7-8-NESTER G52739 MWCE-18-7-5-NESTER G23521 MWCE-18-3-3-NESTER G52732 MWCE-18-5-3-NESTER-01 G47334 MWCE-18-7-6-NESTER G5273
| Date | May 5, 2022 |
| Status | Open, Classified |
| 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 |
| Quantity | 106,033 |
| Distribution | Domestic distribution nationwide. Foreign distribution worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153778 | Nester Embolization Coils, Tornado Embolization Coils Cook Incorporated, May 19, 2016 |