FDA Medical Device Recalls (openFDA)
Cook Incorporated: 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)
- Recall number
- Z-1762-2025
- Recalling firm
- Cook Incorporated
- 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)
- Status
- Open, Classified
- Initiated
- 2025-04-17
- Posted
- 2025-05-14
- Terminated
- not on file
- Reason
- Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 2952 units
- Distribution
- worldwide - No US distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KRD
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28