BEUDAMED
    FDA Recall Terminated

    Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011

    Recall: Z-0729-04 · Initiated February 13, 2004

    Recall

    Recall Number
    Z-0729-04
    Event Number
    28447
    Firm
    Boston Scientific Scimed
    FEI Number
    3002095335
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 13, 2004
    Posted
    July 20, 2004
    Terminated
    December 28, 2006
    Address
    1 Scimed Pl, Maple Grove, MN, 55311-1565

    Description

    Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011

    Reason

    Some of the catheters may have yellow foreign material in their pigtail tips. The foreign material in the device could cause a stroke or significant damage to organs other than the brain.

    Action

    Consignees were sent a recall letter dated February 13, 2004. The letter requested that consignees discontinue use of the recalled catheters and return them.

    Distribution

    The product was shipped to consignees in Florida in the United States.

    Quantity

    11 catheters