FDA Device recall Z-1242-2022
Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2…
- FDA Device
- Class II
- ongoing
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2… 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-1242-2022 |
| 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
Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01 G47416 MWCE-18S-4/2-TORNADO-01 G47417 MWCE-18S-3/2-TORNADO-081800 G13102 MWCE-18S-3/2-TORNADO G08261 MWCE-18S-4/2-TORNADO-081800 G13103 MWCE-18S-4/2-TORNADO G08357 MWCE-18S-5/2-TORNADO-01 G47418 MWCE-18S-6/2-TORNADO-01 G47419 MWCE-18S-6/2-TORNADO-081800 G13105 MWCE-18S-5/2-TORNADO-081800 G13104 MWCE-18S-2/4-TORNADO-LEF G09945 MWCE-18S-2/5-TORNADO-LEF-081800 G13108 MWCE-18S-4/3-TORNADO G12924 MWCE-18S-2/3-TORNADO-LEF G09944 MWCE-18S-2/3-TORNADO-LEF-081800 G13106 MWCE-18S-2/4-TORNADO-LEF-081800 G13107
Reason
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
Identifiers
| code_info | Lots: 14220596 14220940 14266927 14266928 14266929 14266930 14266931 14270156 14270688 NS14220942 14173005 14173006 14…Lots: 14220596 14220940 14266927 14266928 14266929 14266930 14266931 14270156 14270688 NS14220942 14173005 14173006 14173009 14174725 14183341 14183343 14183344 14183345 14183346 14183347 14185759 14185762 14185763 14185764 14185765 NS14183348 14144260 14144261 14149518 14151428 14165309 14176799 14176801 14176802 14176804 14181260 14181262 14181263 14195340 14195341 14195342 14198726 14198727 14198728 14198729 14198730 14198731 14198732 14202396 14202397 14202398 14205449 NS14202553 14149487 14158173 14159388 14173007 14202382 14205450 14208005 14208006 14208007 14208008 14208009 14210749 14210750 14210751 NS14202380 NS14202381 14158174 14159387 14181258 14181259 14188217 14188363 14188366 14195343 14195344 14195345 14196666 14196669 14202556 14210752 14210753 14210754 14212795 14212796 14212797 14212798 14212800 14212801 14212802 14215747 NS14188216 NS14188218 NS14188219 NS14212799 14250738 14250742 14250743 14253965 14254863 14254864 14254865 14254866 14254867 14236671 14236672 142 |
|---|
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-1242-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.