BEUDAMED
    FDA Recall Completed

    IceSphere" 1.5 CX 90 Cryoablation Needle

    Recall: Z-0664-2021 · Initiated November 18, 2020

    Recall

    Recall Number
    Z-0664-2021
    Event Number
    86777
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    GEH
    Status
    Completed
    Root Cause
    Under Investigation by firm
    Initiated
    November 18, 2020
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    IceSphere" 1.5 CX 90 Cryoablation Needle

    Reason

    Complaint trend regarding needle shaft gas leaks.

    Action

    Customers will be sent a product advisory via overnight mail.

    Distribution

    Nationwide

    Quantity

    6,363 units