BEUDAMED
    FDA Recall Terminated

    SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.

    Recall: Z-1691-2015 · Initiated March 19, 2015

    Recall

    Recall Number
    Z-1691-2015
    Event Number
    70772
    Firm
    Biosense Webster, Inc.
    FEI Number
    3003113629
    Product Code
    OAE
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 19, 2015
    Posted
    May 28, 2015
    Terminated
    June 17, 2015
    Address
    15715 Arrow Hwy, Irwindale, CA, 91706-2006

    Description

    SMARTABLATE RF Generator System, Catalog No. M490006, M490007, M4900106, and M4900107. Product Usage: The use of the SMART ABLATE Generator and all accessories is indicated in combination with compatible therapeutic catheters for use in conventional intracardiac RF ablation procedures. The SMARTABLATE Foot Pedal is designed to initiate or discontinue operation of the SMARTABLATE System. The Foot Pedal can be connected to the SMARTABLATE RF Generator, SMARTABLATE Irrigation Pump; or SMARTABLATE Remote Control.

    Reason

    Biosense Webster is recalling the SMARTABLATE Generator System because Biosense Webster has received two complaints reporting that during an RMT procedure the SMARTABLATE RF Generator inadvertently delivered RF energy.

    Action

    Biosense Webster sent an Urgent Field Safety Notification Letter dated March 18, 2015 via FedEx to all their customers that received the affected SMARTABLATE Generator System. The letter informs the customers of the problems identified and the actions to be taken. Biosense Webster is taking precautionary safety measures of reinforcing the Warnings in the Instructions for Use (IFU) for the SMARTABLATE System Foot Pedal. Customers with questions related to the are instructed to contact their local Biosense Webster sales representative or call (866) 473-7823, Monday through Friday from 7:00AM to 8:00PM EST. Customers with questions related to the voluntary field removal certification form and its return, are instructed to contact Elie Ghattas Field Action Coordinator at (909) 839-7281.

    Distribution

    Worldwide Distribution - US Nationwide in the state of: CA, IL, KY, NJ, PA and the countries of: Czech Republic, Denmark, Finland, France, Germany, and Sweden.

    Quantity

    115 units