Recall Z-0896-2015 ยท DXX System, Catheter Control, Steerable
Hansen Medical Inc
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 dat
| Date | Dec 30, 2014 (initiated Dec 4, 2014) |
| Status | Terminated |
| 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. |
| Root cause | Device Design |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052480 | HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATH Hansen Medical, Inc., May 2, 2007 |
| K073225 | SENSEI CATHETER CONTROL SYSTEM Hansen Medical, Inc., Jun 30, 2008 |
| K091808 | SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057 Hansen Medical, Inc., Sep 10, 2009 |
| K102168 | SENSEI X ROBOTIC CATHETER SYSTEM Hansen Medical, Inc., Oct 22, 2010 |
| K141822 | SENSEI X ROBOTIC CATHETER SYSTEM Hanson Medical, Inc., Aug 5, 2014 |