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Cook Incorporated recalls Tornado Embolization Microcoil, intended for embolization of selective vessel supply to arteriovenous malformations and
Recalled May 21, 2025 · FDA recall Z-1762-2025 · Cook Incorporated
Hazard
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil. · FDA Class II
Units
2952 units
Sold at
worldwide - No US distribution.
Description
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
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)
Manufacturer(s)
Cook Incorporated
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →