Reported Jan 7, 2015 · Terminated
Sensei X Robotic Catheter System, model numbers 02057 and 08257. - Set up joint (SUJ)mechanical clamp that secures the…
Hansen Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hansen Medical Inc · 800 E Middlefield Rd · Mountain View, CA · 94043-4030
Is this the product you have?
- 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 UsageThe 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
- Lot codes and dates
- Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.
- Amount recalled
- 59 USA, 40 OUS
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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