Events

Recall of ClearSight 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-2017-RN-01537-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-22
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01537-1
  • 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 been made aware of reports of “out of range” error messages for the edwards clearsight heart reference sensor. an analysis of evhrs out of range complaints led to the determination that the product is not meeting the current labelled shelf life (expiry date) of 730 days (2 years) from the date of manufacture. as a result, edwards lifesciences are amending the expiration date to six months from the date of manufacture. there have been no reported patient injuries as a result of this issue.
  • Action
    Edwards Lifesciences are advising customers that they will be in contact with affected users to arrange for replacement of the device. In the interim, if users do not encounter the "HRS Out of Range" message on the EV1000 clinical platform, the HRS is functioning properly and patient monitoring is not adversely impacted.

Device

ClearSight Heart Reference Sensor
  • Model / Serial
    ClearSight Heart Reference SensorModel Number: EVHRSAll serial numbers manufactured after December 31, 2015ARTG Number: 219809
  • Manufacturer
    Edwards Lifesciences Pty Ltd

Manufacturer

Edwards Lifesciences Pty Ltd