BEUDAMED
    FDA Enforcement Class II Completed

    IceRod" i-Thaw" Prostate Cryoablation Kit

    Recall: Z-0691-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0691-2021
    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

    IceRod" i-Thaw" Prostate Cryoablation Kit

    Reason

    Complaint trend regarding needle shaft gas leaks.

    Code Info

    UPN: FPRPR4070 UDIs: 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830105, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830075, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830099, 7290104830105 Batch Numbers: U1363, U0865, U0555, U0542, U0151, U0150, U0054, U0053, U0046, U0037, U0036, T0633, T0515, T0430, T0274, T0273, T0201, T0188, T0167, A7174, A7100, A7044, A7022, A7021, A6788, A6740, A2117, A2019, A1968, A1753, A1605, A1535, A1430, A1429, A1235, U1262, U1114, U1036, U0910, U0909, U0863, U0365, U0280, U0281, U0180, U0088, U0038, T0529, T0457, T0235, T0178, T0058, A6911, A6835, A6695, A6648, A2133, A2040, A2033, A1889, A1634, A1368, A1225, G5063, G5871, G5900, G5902, G5975, P1901

    Distribution

    Nationwide

    Quantity

    243 units