BEUDAMED
    FDA Enforcement Class II Completed

    IceSeed" 1.5 MRI Cryoablation Needle

    Recall: Z-0681-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0681-2021
    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

    IceSeed" 1.5 MRI Cryoablation Needle

    Reason

    Complaint trend regarding needle shaft gas leaks.

    Code Info

    UPN: FPRPR3192 UDIs: 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266, 7290104830266 Batch Numbers: U1438, U1439, U0962, U0961, U0437, U0378, T0697, T0688, T0388, T0387, A7150, A7149, A2018, A2017, A1711, A1710, A1689, A1403, A1404, A0896, A0897

    Distribution

    Nationwide

    Quantity

    627 units