BEUDAMED
    FDA Recall Open, Classified

    ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy

    Recall: Z-0915-2022 · Initiated March 8, 2022

    Recall

    Recall Number
    Z-0915-2022
    Event Number
    89753
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    MCX
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    March 8, 2022
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    ROTAWIRE Drive and wireClip Torquer, ROTAWIRE Drive Floppy

    Reason

    Pouch seals may be open, compromising sterility.

    Action

    US consignees were mailed an overnight delivery of the customer letter. OUS consignees will be contacted by letter delivery or email. Accounts are asked to return any unused affected devices to the recalling firm. The customer letter provides customers with the product segregation and return instructions and accounts are asked to complete a Reply Verification Tracking Form indicating that they have received the field removal and followed the included instructions.

    Distribution

    Distribution in the US and territories, Japan, and Canada

    Quantity

    433 5-packs