Events

Recall of Edwards Lifesciences Heart Reference Sensor

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Edwards Lifesciences Pty Ltd.

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
    RC-2015-RN-00162-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-03-03
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00162-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    Edwards lifesciences has identified that during setup the heart reference sensor (hrs) may display the error message “hrs: out of range” when the hrs system will not zero. this could prevent patient monitoring with the patient’s haemodynamic status using the clearsight non-invasive system.
  • Action
    If an 'HRS: Out of Range' message is displayed customers are requested to contact Edwards Lifesciences for a replacement device. This action has been closed-out on 09/08/2016.

Device

Edwards Lifesciences Heart Reference Sensor
  • Model / Serial
    Edwards Lifesciences Heart Reference SensorModel Number: EVHRSARTG Number: 219809
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd