FDA Device recall Z-1240-2022
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499)
- FDA Device
- Class II
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499) by Cook, citing the loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1240-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-05-05 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Cook |
| Distribution | US |
Product
Hilal Embolization Microcoil, RPN MWCE-18-1.0-0-HILAL-01 (GPN G47499); RPN MWCE-18-0.5-0-HILAL-01 (GPN G47498)
Reason
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Identifiers
| code_info | Lots: 14212811 14215685 14212247 14212812 14212814 14215682 14361413 14361416 14285326 14285328 14285330 14297289 1436…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1240-2022%22
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