BEUDAMED
    FDA Enforcement Class II Completed

    IceSphere" 1.5 90¿ Cryoablation Needle

    Recall: Z-0673-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0673-2021
    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

    IceSphere" 1.5 90¿ Cryoablation Needle

    Reason

    Complaint trend regarding needle shaft gas leaks.

    Code Info

    UPN: FPRPR3260 UDIs: 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259, 07290104830259 Batch Numbers: U0326, U0325, U0286, U0285, A7012, A7011

    Distribution

    Nationwide

    Quantity

    92 units