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FDAApril 17, 2025device

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)

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.

What to do

FDA enforcement status: Ongoing

Brands named

cook

UPCs

008270020826180082700208357800827002131026

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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