Z-0896-2015Class II

Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that...

Name: Z-0896-2015 Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that...
Creator: Hansen Medical Inc
Published: 2014-12-04
License: https://open.fda.gov/license/

Hansen Medical, Inc. / initiated 2014-12-04 / Terminated / root cause: design

FDA source

Hansen Medical Inc began a recall of 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... on 2014-12-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0896-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-04
Posted: 2014-12-30
Terminated: 2015-09-03
Recalling firm: Hansen Medical, Inc.
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.
Product code: DXX System, Catheter Control, Steerable
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.
Root cause tag: design
FDA 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 in commerce: 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.
Product codes and lots: Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0896-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0896-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-07	2014-12-30

Product code DXX

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)