Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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
Affected units: 2,952

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.

Same manufacturer · Cook Incorporated

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