The Recall Desk
HighFDA (Devices)·Z-1762-2025·Announced 2025-05-21

Cook Tornado Embolization Microcoils Recalled for Incorrect Sizing

Cook Incorporated is recalling Tornado Embolization Microcoils due to incorrect coil sizing. Affected devices may not function properly during vascular procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall for a functional defect (incorrectly sized coils) with no reported illnesses or injuries. An embolization device with sizing defects constitutes a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for High severity.

Plain-English summary

Cook Incorporated is recalling Tornado Embolization Microcoils (model numbers MWCE-18S-3/2-TORNADO, MWCE-18S-4/2-TORNADO, and MWCE-18S-3/2-TORNADO-081800) because some devices may contain incorrectly sized embolization coils. These microcoils are designed to block blood vessels to treat arteriovenous malformations and other vascular lesions.

The recall affects approximately 2,952 units across multiple lot numbers including 16183145, 16183146, 16194351, 16196532, 16196533, 16197253, NS16188093, NS16192163, and others. The devices were distributed worldwide with no reported US distribution.

Healthcare facilities that have received affected devices should verify lot numbers against the recall list and discontinue use of affected units. Physicians and patients who have received treatment with affected devices should consult with their healthcare provider regarding any follow-up care.

The recalled product

Product
Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN MWCE-18S-3/2-TORNADO (GPN G08261), RPN MWCE-18S-3/2-TORNADO-081800 (GPN G13102), RPN MWCE-18S-4/2-TORNADO (GPN G08357)
Manufacturer
Cook Incorporated
Category
Medical Device — Cardiovascular / Embolization
Hazard
  • incorrect-sizing
  • device-malfunction

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • MWCE-18S-3/2-TORNADO
  • UDI-DI: 00827002082618
  • MWCE-18S-4/2-TORNADO
  • UDI-DI: 00827002083578
  • Lot Numbers: 16178639 16181782 16181783 16181784 16186101 NS16178638
  • MWCE-18S-3/2-TORNADO-081800
  • UDI-DI: 00827002131026
  • Lot Numbers: 16188094 16188095

Distribution

Distribution scope not specified by the agency.

Related recalls

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