BEUDAMED
    FDA Enforcement Class II Completed

    Five IceRod" i-Thaw" Prostate Cryoablation Kit

    Recall: Z-0690-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0690-2021
    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

    Five IceRod" i-Thaw" Prostate Cryoablation Kit

    Reason

    Complaint trend regarding needle shaft gas leaks.

    Code Info

    UPN: FPRPR3571 UDIs: 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976, 7290104830976 Batch Numbers: U1264, U1226, U1089, U1012, U1009, U0827, U0772, U0767, U0491, T0817, T0693, T0725, T0587, T0487, T0486, T0313, A7114, A6823, A2113, A1942, A1712, A1257, A1252

    Distribution

    Nationwide

    Quantity

    178 units