Events

Recall of Device Recall Sensei X Robotic Catheter System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hansen Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    69855
  • Event Risk Class
    Class 2
  • Event Number
    Z-0896-2015
  • Event Initiated Date
    2014-12-04
  • Event Date Posted
    2014-12-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131725
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, catheter control, steerable - Product Code DXX
  • 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.

Device

Device Recall Sensei X Robotic Catheter System
  • Model / Serial
    Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.
  • Product 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.
  • Manufacturer
    Hansen Medical Inc

Manufacturer

Hansen Medical Inc
  • Manufacturer Address
    Hansen Medical Inc, 800 E Middlefield Rd, Mountain View CA 94043-4030
  • Manufacturer Parent Company (2017)
    Auris Health, Inc.
  • Source
    USFDA