Cook Incorporated recalls Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and…

Recall date

April 17, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1762-2025

FDA classification

Class II

Brand / firm

Cook Incorporated

Sold / distributed

worldwide - No US distribution.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)