BEUDAMED
    FDA Recall Open, Classified

    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)

    Recall: Z-1762-2025 · Initiated April 17, 2025

    Recall

    Recall Number
    Z-1762-2025
    Event Number
    96702
    Firm
    Cook Incorporated
    FEI Number
    1820334
    Product Code
    KRD
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    April 17, 2025
    Posted
    May 14, 2025
    Address
    750 N Daniels Way, Bloomington, IN, 47404-9120

    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)

    Reason

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

    Action

    An Urgent Field Safety Notice Medical Device Removal notification letter dated 4/17/25 was sent to customers. Actions To Be Taken by the User Identify Device(s) Quarantine Device(s) Return Device(s) to Cook Medical Other Please complete the enclosed Customer Reply Form. Where devices are indicated as being returned, our Customer Services department will contact you to organize the return and issue you with the relevant Returns Authorization number. Please include contact details on the Customer Reply form. Returned Device(s) should be addressed to: Cook Medical EUDC Robert-Koch-Strae, 2 52499 Baesweiler GERMANY Credit will be provided for the returned affected device(s) where applicable.

    Distribution

    worldwide - No US distribution.

    Quantity

    2952 units