BEUDAMED
    FDA Enforcement Class II Completed

    IcePearl" 2.1 CX Prostate Cryoablation Kit

    Recall: Z-0683-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0683-2021
    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

    IcePearl" 2.1 CX Prostate Cryoablation Kit

    Reason

    Complaint trend regarding needle shaft gas leaks.

    Code Info

    UPN: FPRPR3606 UDIs: 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041, 7290104831041 Batch Numbers: U1473, U1299, U1300, U1261, U1213, U1109, U1039, U1031, U0925, U0924, U0858, U0784, U0614, U0613, U0582, U0554, U0226, U0227, U0093, U0027, U0082, T0592, T0437, T0268, T0237, T0236, T0224, T0141, T0136, T0054, A7148, A7088, A7026, A7013, A6925, A6856, A6743, A6702, A2121, A2118, A1936, A1582, A1561, A1460, A1248, A1171

    Distribution

    Nationwide

    Quantity

    215 units