Z-1762-2025Class II

Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous...

Name: Z-1762-2025 Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous...
Creator: Cook Incorporated
Published: 2025-04-17
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2025-04-17 / Open, Classified / root cause: manufacturing process

FDA source

Cook Incorporated began a recall of Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and other vascular lesions, RPN... on 2025-04-17. FDA classified it as Class II and gives the reason as "Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1762-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-04-17
Posted: 2025-05-14
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)
Product code: KRD Device, Vascular, For Promoting Embolization
Reason for recall: Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Root cause tag: manufacturing process
FDA 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 in commerce: 2952 units
Distribution: worldwide - No US distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1762-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1762-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-05-21	2025-05-14

Product code KRD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)