Hansen Medical Inc

Lot number 20151117

Cardiovascular Devices

2

No

Nationwide Distribution to OH, TX. FL, CA and GA.

Magellan Robotic Catheter Accessory Kits, || Model number MACC 50 and MACC80. || Cardiology: The Hansen Medical Magellan System is a robotic control system that enables positioning and visualization of a Magellan Catheter and an off-the-shelf guide wire while allowing a physician to remain seated and away from the x-ray radiation source. The Accessory Kits contain disposable components that keep the Magellan Catheters and 3rd-party guide wires performing smoothly during system operation.

All serial numbers.

Cardiovascular Devices

2

No

Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.

Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.

Model numbers 02057 and 08257, all installed Sensei X Robotic systems are subject to this action.

Cardiovascular Devices

2

No

Worldwide Distribution - US Nationwide and the countries of Italy, Czech Republic, Russia, Spain, Singapore, France, Germany, Denmark, Netherlands and Australia.

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.