BEUDAMED
    FDA Enforcement Class II Completed

    IceFORCE" 2.1 CX Prostate Cryoablation Kit

    Recall: Z-0682-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0682-2021
    Event ID
    86777
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2020
    Initiation Date
    November 18, 2020
    Classification Date
    December 22, 2020
    Address
    1 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States

    Description

    IceFORCE" 2.1 CX Prostate Cryoablation Kit

    Reason

    Complaint trend regarding needle shaft gas leaks.

    Code Info

    UPN: FPRPR3605 UDIs: 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034, 7290104831034 Batch Numbers: U1030, U0904, U0864, U0856, U0763, U0649, T0153, A7062, A7061, A6930, A6758, A1781, A1776, A1565, A1550, A1435, A1291

    Distribution

    Nationwide

    Quantity

    85 units