BEUDAMED
    FDA Enforcement Class II Terminated

    Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)

    Recall: Z-2645-2017 · Reported July 12, 2017

    Enforcement

    Recall Number
    Z-2645-2017
    Event ID
    76772
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 12, 2017
    Initiation Date
    December 15, 2016
    Classification Date
    June 30, 2017
    Termination Date
    April 10, 2018
    Address
    2 Scimed Pl, N/A, Maple Grove, MN, 55311-1565, United States

    Description

    Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inner package UPN)

    Reason

    A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.

    Code Info

    Lot: 00112758, Use by 2018-05-11

    Distribution

    CA, FL, KY, MO, NM, OK, OR, PA, and TX.

    Quantity

    39 boxes of 5 (195 units)