BEUDAMED
    FDA Recall Terminated

    Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufactured by Hansen Medical, Inc, Mountain View, CA

    Recall: Z-1251-2010 · Initiated October 19, 2009

    Recall

    Recall Number
    Z-1251-2010
    Event Number
    54144
    Firm
    Hansen Medical Inc
    FEI Number
    3006026430
    Product Code
    DXX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 19, 2009
    Posted
    April 6, 2010
    Terminated
    February 9, 2011
    Address
    380 N. Bernardo Ave., Mountain View, CA, 94043-5207

    Description

    Artisan brand Extend Control Catheter; An Steerable Guide Catheter; Component of Sensei X Robotic Catheter System; Model Number: 07546; Distributed and Manufactured by Hansen Medical, Inc, Mountain View, CA

    Reason

    Certain Artisan Extend Catheters may develop a leak in the flush assembly of the catheter which has the potential to cause flush fluid leakage and subsequent decrease in distal flush; inability to aspirate air from flush lines, and/or introduction of air into the catheter.

    Action

    Recall Initiation Date: October 19,2009 (FedEx shipments on October 19, for October 20 delivery) via letters explaining the reason for the recall and requesting the product be returned. Customers with questions are instructed to call the company at 650-404-5940.

    Distribution

    Nationwide to 12 states.