BEUDAMED
    FDA Recall 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 · Initiated July 31, 2015

    Recall

    Recall Number
    Z-2380-2015
    Event Number
    71849
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    DXE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    July 31, 2015
    Posted
    August 13, 2015
    Terminated
    February 5, 2016
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    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.

    Action

    Boston Scientific sent an Urgent Medical Device Recall Removal letter dated July 31, 2015, to all affected consignees. The letter described the problem and the affected product. Consignees were advised to segregate the affected product and return it to Boston Scientific. They were also requested consignees to complete and return the Account Reply Verification Tracking Form. Contact your Sales Representative for any questions. For questions regarding this recall call 763-494-1556.

    Distribution

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

    Quantity

    total of 9 units