BEUDAMED
    FDA Recall Terminated

    Boston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in intravascular interventional procedures.

    Recall: Z-1487-2009 · Initiated May 12, 2009

    Recall

    Recall Number
    Z-1487-2009
    Event Number
    52098
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 12, 2009
    Posted
    June 24, 2009
    Terminated
    December 11, 2011
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Boston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in intravascular interventional procedures.

    Reason

    Product packaged incorrectly. One batch/lot of wires, that should contain radiopaque marker bands, is missing the marker bands; and a second batch/lot of wires, which should not contain radiopaque marker bands, has the marker bands. Since the marker bands issue would not be visually apparent to the physician there is a potential for prolongation or delay of the procedure in order to exchange the

    Action

    Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated may 19, 2009. The letter was addressed to "Dear Risk Manger/ Field Action Contact". The letter described the problem, customer steps for recall and listing of product batches / lots. The letter requested consignees to return the Reply Verification Tracking Form.

    Distribution

    USA distribution: AR, MO, CA, FL, and NV.

    Quantity

    Total of 4 boxes (5 units /box).