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

Tornado Embolization Microcoil recalled for incorrectly sized coils

Cook Incorporated is recalling Tornado Embolization Microcoils due to incorrectly sized coils in affected lots. The devices are used for vascular embolization 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 recall of a medical device with a functional defect that could affect patient safety during vascular procedures. The source text does not report any illnesses or injuries, but the risk-of-harm nature of an incorrectly sized embolization coil in an interventional device justifies a High severity rating.

Plain-English summary

Cook Incorporated has identified that devices from affected lots of the Tornado Embolization Microcoil may contain incorrectly sized embolization coils. This device is intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions.

The recall affects three product variants: MWCE-18S-3/2-TORNADO (UDI-DI: 00827002082618), MWCE-18S-4/2-TORNADO (UDI-DI: 00827002083578), and MWCE-18S-3/2-TORNADO-081800 (UDI-DI: 00827002131026). A total of 2,952 units have been distributed worldwide with no US distribution.

Healthcare providers and facilities that have received any of the affected lots should discontinue use and contact Cook Incorporated for further instructions regarding device replacement and proper handling.

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 — Vascular Intervention
Hazard
  • device-malfunction
  • sizing-defect

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.

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