BEUDAMED
    FDA Recall Terminated

    Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic implantable pumps) The catheter is designed for use in the intrathecal space. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.

    Recall: Z-1414-06 · Initiated July 21, 2006

    Recall

    Recall Number
    Z-1414-06
    Event Number
    35931
    Firm
    Medtronic Neurological
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 21, 2006
    Posted
    September 9, 2006
    Terminated
    June 21, 2007
    Address
    800 53rd Ave NE PO Box 1250, Minneapolis, MN, 55440-1250

    Description

    Medtronic Intrathecal Catheter, Model 8731, (part of infusion systems using Medtronic implantable pumps) The catheter is designed for use in the intrathecal space. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.

    Reason

    Tip dislodgement during implantation-Medtronic is recalling Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit because the platinum-iridium tip may be dislodged by the guide wire during implantation.

    Action

    An Urgent Worldwide Medical Device Recall letter was sent to affected customers 07/20/06 for delivery on 07/21/06. The letter describes the issue, identifies the affected product and list action required by the customer. Affected devices are to be removed from active inventory, quarantined and returned to Medtronic for a warranty credit. A Reply card is asked to be returned. Medtronic Representatives will follow-up by July 28, 2006.

    Distribution

    Worldwide Distribution-USA and Austria, Belgium, Canada, Cyprus, Denmark, Finland, France, Germany, Greece, India, Ireland, Italy, Netherlands, Norway, Poland, Portugal, San Marino, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, and the United Kingdom

    Quantity

    Recalls Z-1414-1415-06-USA - 359 devices. Foreign - 575 devices