Events

Recall of EV1000 NI HEART REFERENCE SENSOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by EDWARDS LIFESCIENCES (CANADA) 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
    49941
  • Event Risk Class
    III
  • Event Initiated Date
    2017-12-12
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Extra notes in the data
  • Reason
    The current product as well as the affiliated labeling contains an expiration date of two years. through investigation and analysis of complaint data edwards lifesciences discovered that hrs units are susceptible to experiencing an "hrs out of range" error message in the ev1000 platform that are beyond six months from the date of manufacture.

Device

EV1000 NI HEART REFERENCE SENSOR
  • Model / Serial
    Model Catalog: EVHRS (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    CLEARSIGHT HEART REFERENCE SENSOR
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.