Sensei X Robotic Catheter System — Class II medical device recall Z-0896-2015
Terminated recall by Hansen Medical Inc, reported 2015-01-07, distributed nationwide. The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operatin
| Recall number | Z-0896-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hansen Medical Inc, Mountain View, CA, United States |
| Recall initiated | 2014-12-04 |
| Classified | 2014-12-30 |
| Reported by FDA | 2015-01-07 |
| Terminated | 2015-09-03 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CZ, DE, DK, ES, FR, IT, NL, RU, SG |
| Model numbers | 02057, 08257 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0896-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.