BEUDAMED
    FDA Recall Terminated

    Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.

    Recall: Z-0896-2015 · Initiated December 4, 2014

    Recall

    Recall Number
    Z-0896-2015
    Event Number
    69855
    Firm
    Hansen Medical Inc
    FEI Number
    3006026430
    Product Code
    DXX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 4, 2014
    Posted
    December 30, 2014
    Terminated
    September 3, 2015
    Address
    800 E Middlefield Rd, Mountain View, CA, 94043-4030

    Description

    Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter laboratory table. Product Usage: The Sensei X Robotic Catheter System is an electromechanical software controlled system designed to facilitate navigation and control of Hansen Medicals robotically steerable catheters for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems.

    Reason

    The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operating table with the potential for the device to fall causing, uncontrolled catheter movement. cardiac tampenade, delayed procedure, or crush injury to the patient and/or user.

    Action

    Hansen Medical sent an Urgent Notice - Field Safety Notice letters to US customers on December 4, 2014 via Federal Express. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete and fax back the attached form to Hansen medical at 650-404-2773. For further information call 650-404-5841.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.

    Quantity

    59 USA, 40 OUS