FDA Device recall Z-0896-2015
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the SUJ to the catheter…
- FDA Device
- Class II
- terminated
- Published 2015-01-07
On 2015-01-07 the FDA classified a Class II 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… by Hansen Medical, citing 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, uncontroll….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0896-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-04 |
| Published | 2015-01-07 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Hansen Medical |
| Distribution | US |
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.
Identifiers
| code_info | Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0896-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.