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-00503-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-06-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00503-1
  • 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
    A component of the clearsight system can be damaged if not handled properly. the heart reference sensor (model number evhrs) compensates for pressure differences between the finger cuff and the heart. the finger component of the evhrs may be damaged if subjected to moderate to significant surface impact.
  • Action
    Edwards Lifesciences is providing work around instructions to assist end users in determining whether the Heart Reference Sensor has been damaged. An insert, included with the recall letter, will be provided with all new EVHRS devices and the Operating Manual of the EV1000NI will be updated on its next release. Edwards Lifesciences is currently working on design changes to avoid the potential for damage to the device and to detect whether damage has been sustained during use. This action has been closed-out on 11/08/2016.

Device

Edwards Lifesciences Heart Reference Sensor

Manufacturer

Edwards Lifesciences Pty Ltd