Events

Recall of Device Recall Magellan Robotic System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hansen Medical Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    70847
  • Event Risk Class
    Class 2
  • Event Number
    Z-1449-2015
  • Event Initiated Date
    2015-03-18
  • Event Date Posted
    2015-04-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135134
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, catheter control, steerable - Product Code DXX
  • Reason
    Based on investigation of two complaint incidents, all hansen medical magellan robotic system (model no. 11132 and 11139) may experience an unexpected event during a retraction operation of catheter. retraction of catheter may not stop when equipment button is released.
  • Action
    Hansen Medical sent an Urgent Notice - Field Safety Notice dated March 24, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. We request that you review the information in pages 1 and 2 with Hansen Medical personnel and acknowledge your understanding by signing the Field Safety Notice Training Form on page 3. If you need any further information regarding this issue, please do not hesitate to contact me via telephone at 650-404-2784.

Device

Device Recall Magellan Robotic System
  • Model / Serial
    All serial numbers.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Distribution and the countries of : Saudi Arabia, Australia, France, Italy, Germany, and United Kingdom.
  • Product Description
    Magellan Robotic System; Model No(s). 11132 and 11139. A steerable catheter control system used at clinical sites.
  • Manufacturer
    Hansen Medical Inc

Manufacturer

Hansen Medical Inc
  • Manufacturer Address
    Hansen Medical Inc, 800 E Middlefield Rd, Mountain View CA 94043-4030
  • Manufacturer Parent Company (2017)
    Auris Health, Inc.
  • Source
    USFDA