Recall Z-0896-2015— Hansen Medical Inc

Name: FDA recall Z-0896-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-04

Class II · Terminated

Class II FDA medical device recall by Hansen Medical Inc, initiated 2014-12-04, terminated 2015-09-03. It names 5 FDA 510(k) clearances: K141822, K102168, K091808 and 2 more. Product: 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..

Recalling firm: Hansen Medical Inc
Classification: Class II
Status: Terminated
Initiated: 2014-12-04
Terminated: 2015-09-03
Firm location: Mountain View, CA, United States

510(k) clearances named in this recall

5 on FDA's record

K141822 — SENSEI X ROBOTIC CATHETER SYSTEMHanson Medical, Inc.·cleared 2014-08-05
K102168 — SENSEI X ROBOTIC CATHETER SYSTEMHansen Medical, Inc.·cleared 2010-10-22
K091808 — SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057Hansen Medical, Inc.·cleared 2009-09-10
K073225 — SENSEI CATHETER CONTROL SYSTEMHansen Medical, Inc.·cleared 2008-06-30
K052480 — HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATHHansen Medical, Inc.·cleared 2007-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.