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.
This recall has been terminated (originally issued December 30, 2014).
- Company
- Hansen Medical Inc
- Recall Initiated
- December 4, 2014
- Posted
- December 30, 2014
- Terminated
- September 3, 2015
- Recall Number
- Z-0896-2015
- Quantity
- 59 USA, 40 OUS
- Firm Location
- Mountain View, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.
Lot / Code Info
Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.
Root Cause
Device Design
Action Taken
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.