Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical c...
FDA Recall #Z-0896-2015 — Class II — December 4, 2014
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.
Reason for Recall
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.
Recalling Firm
Hansen Medical Inc — Mountain View, CA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
59 USA, 40 OUS
Distribution
Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.
Code Information
Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated