Reported Jun 15, 2022 · Ongoing
Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259 MWCE-18S-3/2-TORNADO-01…
Cook Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
18 of 18 products
| Model / number | Product as published |
|---|---|
G08356 | Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO |
G08259 | MWCE-18S-6/2-TORNADO |
G47416 | MWCE-18S-3/2-TORNADO-01 |
G47417 | MWCE-18S-4/2-TORNADO-01 |
G13102 | MWCE-18S-3/2-TORNADO-081800 |
G08261 | MWCE-18S-3/2-TORNADO |
G13103 | MWCE-18S-4/2-TORNADO-081800 |
G08357 | MWCE-18S-4/2-TORNADO |
G47418 | MWCE-18S-5/2-TORNADO-01 |
G47419 | MWCE-18S-6/2-TORNADO-01 |
G13105 | MWCE-18S-6/2-TORNADO-081800 |
G13104 | MWCE-18S-5/2-TORNADO-081800 |
G09945 | MWCE-18S-2/4-TORNADO-LEF |
G13108 | MWCE-18S-2/5-TORNADO-LEF-081800 |
G12924 | MWCE-18S-4/3-TORNADO |
G09944 | MWCE-18S-2/3-TORNADO-LEF |
G13106 | MWCE-18S-2/3-TORNADO-LEF-081800 |
G13107 | MWCE-18S-2/4-TORNADO-LEF-081800 |
- Lot codes and dates
- Lots
864 of 864 codes
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(01)00827002082595(17)270112(10)NS14410623 (01)00827002474192(17)270124(10)14434592 (01)00827002474185(17)270206(10)14445421 (01)00827002083578(17)270211(10)14492887 (01)00827002083578(17)270211(10)14495701 (01)00827002082618(17)270211(10)14495702 (01)00827002474178(17)270217(10)14495704 (01)00827002474161(17)270217(10)14495705 (01)00827002082595(17)270120(10)14431474 (01)00827002083578(17)270121(10)14469248 (01)00827002083578(17)270120(10)14469249 (01)00827002083578(17)270120(10)14469250 (01)00827002131033(17)270124(10)14469251 (01)00827002083578(17)270124(10)14469252 (01)00827002474178(17)270128(10)14483961 (01)00827002083578(17)270125(10)14483962 (01)00827002129245(17)270202(10)14486089 (01)00827002083578(17)270201(10)14486090 (01)00827002474161(17)270131(10)14486091 (01)00827002083578(17)270202(10)14486092 (01)00827002083578(17)270207(10)14486093 (01)00827002083578(17)270207
- Lots
- Amount recalled
- 106,033
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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