The Recall Desk

Manufacturer

Hansen Medical Inc

3 recalls in our database name Hansen Medical Inc as the manufacturing or recalling firm.

What the numbers show

Total
3
Critical
0
Severe
1
Most recent
2016-05-04

Of the 3 recalls from Hansen Medical Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (33%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–3 of 3

  • ModerateFDA (Devices)·Z-1564-2016·2016-05-04

    Hansen Medical Recalls Magellan Robotic Catheter Accessory Kits

    Hansen Medical is recalling eight Magellan Robotic Catheter Accessory Kits because one batch was radiated below the required dose.

    Product
    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 t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1449-2015·2015-04-22

    Hansen Medical Recalls Magellan Robotic Systems Due to Catheter Retraction Defect

    Hansen Medical is recalling 19 Magellan Robotic Systems because the catheter may fail to stop retracting when the control button is released.

    Product
    Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-0896-2015·2015-01-07

    Hansen Medical Recalls Sensei X Robotic Catheter Systems Due to Loose Clamp

    Hansen Medical is recalling Sensei X Robotic Catheter Systems because a mechanical clamp may become loose, causing the device to fall and potentially injure patients or users.

    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 f
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Hansen Medical

American medical appliances and equipment company

Country
United States
Founded
2002

Official website

Source: Wikidata (Q5651043), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.