BEUDAMED
    FDA Recall Terminated

    Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029

    Recall: Z-0523-04 · Initiated January 14, 2004

    Recall

    Recall Number
    Z-0523-04
    Event Number
    28128
    Firm
    Medtronic, Inc.
    FEI Number
    1220452
    Product Code
    DQO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 14, 2004
    Posted
    February 10, 2004
    Terminated
    November 15, 2004
    Address
    37a Cherry Hill Dr, Danvers, MA, 01923-2565

    Description

    Medtronic SiteSeer 5 F Tight Radius 145 Pigtail Cardiovascular Angiographic Catheter Item Number: 5A0029

    Reason

    Catheter distal tip may separate

    Action

    Medtronic notified sales representatives/distributors on 1/14/04 via telephone and email and requested to retrieve affected product from the hospitals and return it to Danvers, MA. A script and effectiveness document was provided and to be reviewed with the hospital.

    Distribution

    NC, WA

    Quantity

    20 units