Tornado recallZ-1762-2025 · Cook Incorporated · initiated Apr 17, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook Incorporated or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
FDA root cause category: Process control
What the company is doing
An Urgent Field Safety Notice Medical Device Removal notification letter dated 4/17/25 was sent to customers. Actions To Be Taken by the User Identify Device(s) Quarantine Device(s) Return Device(s) to Cook Medical Other Please complete the enclosed Customer Reply Form. Where devices are indicated as being returned, our Customer Services department will contact you to organize the return and issue you with the relevant Returns Authorization number. Please include contact details on the Customer Reply form. Returned Device(s) should be addressed to: Cook Medical EUDC Robert-Koch-Strae, 2 52499 Baesweiler GERMANY Credit will be provided for the returned affected device(s) where applicable.
Recall details
- Recall number
- Z-1762-2025
- Status
- Open, Classified
- Initiated by the company
- Apr 17, 2025
- Posted by the FDA
- May 14, 2025
- Recalling firm
- Cook Incorporated
- Quantity
- 2952 units
- Product code
- KRD
- Distribution
- worldwide - No US distribution.
Product description
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)
Code information (models, lots, serial numbers)
MWCE-18S-3/2-TORNADO, UDI-DI: 00827002082618, Lot Numbers: 16183145 16183146 16194351 16196532 16196533 16197253 NS16188093 NS16192163 16196534 16196535 16197247 16197248 16197249 16197250 16197251 16197252 16204238 NS16199061 16233647 16233648 16233649 NS16233646; 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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Tornado G08261Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls7 reports
- Tornado G08357Cook Incorporated · Device, Vascular, for Promoting Embolization2 recalls1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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