BEUDAMED
    FDA Recall Terminated

    Guidant ENDOTAK SQ Array models 0048, 0049, 0085. Subcutaneous Lead Array. Cardioversion/Defibrillation Lead. Guidant Corporation Cardiac Rhythm Management 4100 Hamline Avenue North, St. Paul, MN 55112-5798. Sterilized with gaseous ethylene oxide.

    Recall: Z-1441-05 · Initiated June 13, 2005

    Recall

    Recall Number
    Z-1441-05
    Event Number
    32395
    Firm
    Guidant Corporation
    FEI Number
    2124215
    Product Code
    DYB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 13, 2005
    Posted
    August 30, 2005
    Terminated
    January 5, 2007
    Address
    4100 Hamline Ave N, Saint Paul, MN, 55112-5700

    Description

    Guidant ENDOTAK SQ Array models 0048, 0049, 0085. Subcutaneous Lead Array. Cardioversion/Defibrillation Lead. Guidant Corporation Cardiac Rhythm Management 4100 Hamline Avenue North, St. Paul, MN 55112-5798. Sterilized with gaseous ethylene oxide.

    Reason

    A manufacturer for Guidant introducers has received reports of introducer sheaths with cracked hubs/handles and /or improper peeling of the sheath during use.

    Action

    By Telephone, 6/13/2005. Guidant Sales Reps are to visit hospitals to remove any remaining inventory. Dear Hospital Administrator letter may be left with hospital to explain the removal of product.

    Distribution

    nationwide and worldwide.

    Quantity

    710