Medical Device Recall: 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-
Cook Incorporated · April 17, 2025
Reason for Recall
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized embolization coil.
Product Description
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)
Distribution
worldwide - No US distribution.
Quantity Affected
2952 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1762-2025
Status: ongoing
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