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Terminated

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.

FDA Recall Z-0896-2015 · Posted 2014-12-30

Recalling FirmHansen Medical Inc
Recall StatusTerminated
Product CodeDXX
Date Initiated2014-12-04
Date Terminated2015-09-03
Product Quantity59 USA, 40 OUS

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102168SENSEI X ROBOTIC CATHETER SYSTEMHansen Medical, Inc. · 2010-10-22K091808SENSEI ROBOTIC CATHETER SYSTEM, MODEL 02057Hansen Medical, Inc. · 2009-09-10K073225SENSEI CATHETER CONTROL SYSTEMHansen Medical, Inc. · 2008-06-30K052480HANSEN MEDICAL CATHETER CONTROL SYSTEM (CCS) AND ACCESSORIES, HANSEN MEDICAL STEERABLE GUIDE CATHETER (SGC) AND SHEATHHansen Medical, Inc. · 2007-05-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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