Class II

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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