Events

Recall of Device Recall Magellan Robotic Catheter System Accessory Kits

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
    73677
  • Event Risk Class
    Class 2
  • Event Number
    Z-1564-2016
  • Event Initiated Date
    2016-03-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144725
  • 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
    Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kgy.
  • Action
    Hansen Medical sent an Urgent Notice Product Recall notification dated March 28, 2016, to all affected customers. The notification identified the product, the problem, and the action to be taken by the customer. Customers were instructed to provide the product to the Hansen Medical field representative to assure credit appropriately applied to their account. Customers with questions were instructed to contact their local Hansen Medical representative or call 650-404-5581.

Device

Device Recall Magellan Robotic Catheter System Accessory Kits
  • Model / Serial
    Lot number 20151117
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to OH, TX. FL, CA and GA.
  • Product Description
    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.
  • 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