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U.S. Department of Health and Human Services

Class 2 Device Recall Tornado Embolization Microcoil

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 Class 2 Device Recall Tornado Embolization Microcoilsee related information
Date Initiated by FirmApril 17, 2025
Date PostedMay 14, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1762-2025
Recall Event ID 96702
Product Classification Device, Vascular, for Promoting Embolization - Product Code KRD
ProductTornado 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 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
Recalling Firm/
Manufacturer		 Cook Incorporated
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Department
812-339-2235 Ext. 15-10
Manufacturer Reason
for Recall		Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
FDA Determined
Cause 2		Process control
ActionAn 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 Commerce2952 units
Distributionworldwide - No US distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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