Hansen Medical Inc

FDA recalling firm · 3 enforcement events · 3 product records · 2014–2016 · CA

Hansen Medical Inc has 3 FDA enforcement events on this register (3 product records) between 2014 and 2016: 3 device; the busiest year was 2014 with 1.

0% of its events are Class I; the most common class is Class II (3). 0 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
25 Mar 2016	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…	Device	Class II	1	Terminated
18 Mar 2015	Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.	Device	Class II	1	Terminated
4 Dec 2014	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…	Device	Class II	1	Terminated

By type and class

Device3

Class II3

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Hansen Medical Inc by year initiated.

Questions and answers

How many FDA recalls has Hansen Medical Inc had?

3 enforcement events (3 product records) on this register, 2014–2016: 3 device.

Are any Hansen Medical Inc recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Hansen Medical Inc recalls?

3 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.