BEUDAMED
    FDA Recall Terminated

    Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02

    Recall: Z-0368-2010 · Initiated October 2, 2008

    Recall

    Recall Number
    Z-0368-2010
    Event Number
    50784
    Firm
    BioSense Webster, Inc. Circuito Interior Norte, # 1820 Parque Industrial Salvarcar Cd. Juarez, Chihuahua Mexico
    FEI Number
    3003248396
    Product Code
    LPB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 2, 2008
    Posted
    November 19, 2009
    Terminated
    November 23, 2009

    Description

    Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02

    Reason

    Biosense Webster initiated the recall because of the potential concern with one of the Printed Circuit Board (PCB) components used in the NaviStar RMT Catheters, which may cause the ablation catheter icon to shift on the map viewer when RF energy is being applied. Therefore the user, attempting a linear ablation in the location displayed on the CARTO RMT screen, may ultimately apply RF energy to u

    Action

    The firm sent an "Urgent Medical Device Correction" letter to consignees on October 6, 2008 informing consignees. Users were advised to pay "close attention to the location of the ablation catheter icon on the map viewer when applying RF energy." If consignees suspect that they have a defective NAVISTAR RMT Catheter, they were instructed to notify Biosense Webster and to return the defective catheter for evaluation and refund/replacement. Customer were instructed to contact their local Biosense Webster representative for any questions or further information. No return reply was requested.

    Distribution

    CA, CT, FL, GA, IA, IL, IN, KS, KY, MA, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, and WI

    Quantity

    2559 units