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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Tornado Embolization Microcoils Recalled for Incorrect Sizing

Agency Publication Date: May 14, 2025
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Summary

Cook Medical is recalling 2,952 units of its Tornado Embolization Microcoils because affected devices may contain incorrectly sized coils. These microcoils are used by healthcare professionals to block blood flow in specific vessels to treat vascular lesions and malformations. No injuries or incidents have been reported in connection with this issue.

Risk

The use of an incorrectly sized embolization coil could lead to improper blockage of blood vessels or the coil migrating to an unintended location. This could result in vascular damage, procedural failure, or the need for additional medical intervention.

What You Should Do

  1. This recall affects Tornado Embolization Microcoils with catalog numbers MWCE-18S-3/2-TORNADO, MWCE-18S-4/2-TORNADO, and MWCE-18S-3/2-TORNADO-081800.
  2. Identify if your product is affected by checking the catalog number and lot number printed on the device label or packaging. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled devices immediately.
  4. Contact Cook Incorporated or your medical distributor to arrange for the return, replacement, or correction of any affected units in your inventory.
  5. For further questions regarding this recall, contact the FDA at 1-888-463-6332 or visit the FDA website at www.fda.gov.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Tornado Embolization Microcoil (MWCE-18S-3/2-TORNADO)
Model / REF:
MWCE-18S-3/2-TORNADO
GPN G08261
Lot Numbers:
16183145
16183146
16194351
16196532
16196533
16197253
NS16188093
NS16192163
16196534
16196535
16197247
16197248
16197249
16197250
16197251
16197252
16204238
NS16199061
16233647
16233648
16233649
NS16233646
UDI:
00827002082618

Intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions.

Product: Tornado Embolization Microcoil (MWCE-18S-4/2-TORNADO)
Model / REF:
MWCE-18S-4/2-TORNADO
GPN G08357
Lot Numbers:
16178639
16181782
16181783
16181784
16186101
NS16178638
UDI:
00827002083578

Intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions.

Product: Tornado Embolization Microcoil (MWCE-18S-3/2-TORNADO-081800)
Model / REF:
MWCE-18S-3/2-TORNADO-081800
GPN G13102
Lot Numbers:
16188094
16188095
UDI:
00827002131026

Intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96702
Status: Active
Manufacturer: Cook Incorporated
Sold By: Hospital supply chains; Medical distributors
Manufactured In: United States
Units Affected: 2952 units

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.