BEUDAMED
    FDA Recall 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 · Initiated December 15, 2016

    Recall

    Recall Number
    Z-2645-2017
    Event Number
    76772
    Firm
    Boston Scientific Corporation
    FEI Number
    3002095335
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    December 15, 2016
    Posted
    June 27, 2017
    Terminated
    April 10, 2018
    Address
    2 Scimed Pl, Maple Grove, MN, 55311-1565

    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.

    Action

    Customers were sent an Urgent Medical Device Removal letter, dated 12/15/2016, via overnight mail delivery beginning 12/15/2016. The letter identified affected product, described the issue, and asked for product to be returned. Removal instructions were provided and a Reply Verification Tracking Form was asked to be returned. Questions can be directed to Nicole Pshon, Field Action Manager at 763-494-1133 or [email protected]

    Distribution

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

    Quantity

    39 boxes of 5 (195 units)