Tornado Embolization Microcoil, RPN GPN MWCE-18S-5/2-TORNADO G08356 MWCE-18S-6/2-TORNADO G08259…
Medical device recall Z-1242-2022. Published in FDA’s Enforcement Report on Jun 15, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 15, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 106,033 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The loading cartridges included with these devices may contain a small, unintended, stainless-steel cannula.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
106,033, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,998 characters
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 14236673 14236674 14236675 14239466 14239467 14239468 14239469 14239470 14239471 14239472 14242269 14242270 14242271 14242272 NS14242268 14195265 14195266 14196667 14196668 14198997 14202554 14220941 14224113 14224114 14224115 14224116 14224117 14230375 14230376 14230379 14236670 14258545 14261429 14261430 14261431 14261432 14261433 14261434 14261435 NS14220945 NS14227791 14198998 14202555 14215746 14215748 14215749 14215750 14215751 14215752 14221686 14221687 14221688 14221689 14227792 14227793 14227794 14227795 14227796 14227797 14230373 14230374 14230377 14230378 NS14218742 NS14220943 NS14220946 NS14227798 NS14227798X 14221684 14221685 14221690 14224118 14242266 14242267 14244118 14244684 14244685 14244686 14244687 14244688 14244689 14244690 14248153 14250739 14250740 14250741 14254868 14258128 14258539 14258540 14258541 14258542 14258543 14258544 NS14258538 14220594 14220595 14273582 14273583 14273584 14297279 14297282 14232891 14273588 14276221 14276226 14276227 14297283 NS14273587…
FDA’s list runs to 43,585 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Domestic distribution nationwide. Foreign distribution worldwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 5, 2022.
- FDA classified it on Jun 6, 2022.
- FDA’s Enforcement Report published it on Jun 15, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Cook Incorporated, of Bloomington, IN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 43,585 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.