Severity
Moderate
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.
Reported: January 7, 2015 Initiated: December 4, 2014 #Z-0896-2015 59 USA, 40 OUS units
The recall
Hansen Medical Inc issued this moderate-severity FDA Devices recall — The Set Up Joint subassembly of the Sensei X Robotic Catheter System may become loose relative to the operati….
- Moderate
- severity level
- 59 USA, 40 OUS
- units affected
- Class II
- classification
- January 7, 2015
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0896-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0896-2015) was formally reported on January 7, 2015, with the manufacturer initiating the action on December 4, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Hansen Medical Inc is listed as the recalling firm, operating out of Mountain View, CA. Federal records indicate 59 USA, 40 OUS units are affected.
The documented reason for this recall is: 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,… Distribution data in the federal record shows the product reached: Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.
Where this recall sits in the database
Of 83,949 recalls in the database, 21,198 are high severity, 58,883 moderate, and 3,868 low. This recall is classified moderate severity.
Units Affected
59 USA, 40 OUS
Related Recalls
6
6 from same agency
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.
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.
Details
- Recalling Firm
- Hansen Medical Inc
- Units Affected
- 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.
- Location
- Mountain View, CA
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0896-2015 |
| Date reported | January 7, 2015 |
| Date initiated | December 4, 2014 |
| Recalling firm | Hansen Medical Inc |
| Units affected | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hansen Medical Inc. Units affected: 59 USA, 40 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 7, 2015. Severity: Moderate. Recall number: Z-0896-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0896-2015) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Recall Guides
Learn how the US recall system works and how to protect yourself and your household.
How the US Recall System Works
The three federal agencies, how recalls are initiated, and what happens next.
Understanding Recall Severity Classes
What Class I, II, and III mean and which recalls demand immediate action.
What to Do When a Product Is Recalled
Verify, claim your remedy, report injuries, and navigate the process.
How to Check If Your Products Are Recalled
Step-by-step guide to checking food, products, medications, and vehicles.
Recalled Products in Your Home
A room-by-room household audit guide for active recalls.
Most Recalled Product Categories
Rankings of highest-recall categories from FDA, CPSC, and NHTSA.
Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
Continue exploring
Keep tracking product safety across the federal recall archive.
Recall Checker
Search the full archive by product name, brand, or recall number across every agency.
Check a product →
FDA Devices recalls
Every recall issued by FDA Devices, newest first.
Browse the feed →
RecallRadar
Live feed of the latest recalls across the FDA, CPSC and NHTSA — filter by agency and severity.
View the live feed →
Rankings
The largest recalls by units affected and the most-recalled product categories.
See the rankings →
Browse by category
Find recalls by product type to spot recurring defect patterns.
All categories →
What to do next
A step-by-step guide to refunds, repairs, and returns after a recall.
Read the guide →
Nearby Recalls in This Category
Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
FDA Devices Moderate
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Waldemar Link GmbH & Co. KG (Mfg Site) · 2026-03-18
FDA Devices Low
Penner Pacific Bathing Spa, Model Numbers 360020-1P
Penner Patient Care, Inc. · 2026-03-18
FDA Devices Moderate
GEM Premier 5000 PAK, Part No. 00055360004.
Instrumentation Laboratory · 2026-03-18
FDA Devices Moderate
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Beckman Coulter Mishima K.K. · 2026-03-18
FDA Devices Critical
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descript…
Trividia Health, Inc. · 2026-03-18
Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →
Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported January 7, 2015.
- Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Read our methodology — how this data is sourced, computed, and verified.
Source: Federal recall agencies (FDA, CPSC, NHTSA) Aggregated federal recall feeds Recall data normalized across FDA, CPSC and NHTSA feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type).