BEUDAMED
    FDA Enforcement Class II Terminated

    AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.

    Recall: Z-2380-2015 · Reported August 19, 2015

    Enforcement

    Recall Number
    Z-2380-2015
    Event ID
    71849
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 19, 2015
    Initiation Date
    July 31, 2015
    Classification Date
    August 13, 2015
    Termination Date
    February 5, 2016
    Address
    1 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States

    Description

    AngioJet AVX Thrombectomy Set: UPN 105039-001, Catalog No.105039, Sterilized Using Ethylene Oxide. For breaking apart and removing thrombus from vascular system, used with the AngioJet Ultra System in breaking apart and removing thrombus from A-V access conduits.

    Reason

    AngioJet products were distributed with an incorrect use-by (expiry) date. The correct date is Nov-2015, but the units are labeled with a use-by date of Dec-2015.

    Code Info

    163390

    Distribution

    Worldwide Distribution - US including AZ, MO, OH and Internationally to GERMANY and SPAIN.

    Quantity

    total of 9 units