Events

Recall of Simulator, invasive blood pressure

According to New Zealand Medicines and Medical Devices Safety Authority, this recall involved a device in New Zealand that was produced by Edwards Lifesciences LLC.

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
    22390
  • Event Initiated Date
    2017-12-20
  • Event Country
    New Zealand
  • Event Source
    NZMMDSA
  • Event Source URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notes / Alerts
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Extra notes in the data
    Recalling Organisation: Edwards Lifesciences (New Zealand) Limited, 171 Morrin Road, St John, Auckland 1072
  • Reason
    The manufacturer have received reports of out of range error messages for the edwards clearsight heart reference sensor. these complaints have increased in the last six (6) months. 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.
  • Action
    Product to be exchanged

Device

Simulator, invasive blood pressure

Manufacturer

Edwards Lifesciences LLC