Hansen Medical Inc: Medical Device Recall in 2015 - (Recall #: Z-0896-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 4, 2014

Date Posted: January 7, 2015

Recall Number: Z-0896-2015

Event ID: 69855

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.

Status: Terminated

Product Quantity: 59 USA, 40 OUS

Code Information:

Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated