Events

Recall of EDWARDS EV1000 SYSTEM - VOLUMEVIEW THERMODILUTION CABLE

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
    152782
  • Event Risk Class
    II
  • Event Initiated Date
    2016-05-26
  • 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
    Edwards lifesciences has initiated a voluntary safety alert regarding the ev1000a system to reinforce the proper set up of the external power supply according to the equipment's operator manual. the company received a recent event of an electrical fire therefore is sending a notice to all customers with ev1000a systems installed to confirm installation against the current requirements documented in the operator's manual section ev1000 power adapter mounting bracket.

Device

EDWARDS EV1000 SYSTEM - VOLUMEVIEW THERMODILUTION CABLE
  • Model / Serial
    Model Catalog: EVVVTC1 (Lot serial: ALL); Model Catalog: EVPSA1 (Lot serial: ALL); Model Catalog: EV1000A (Lot serial: ALL); Model Catalog: EVDBB1 (Lot serial: ALL); Model Catalog: EVFTC1 (Lot serial: ALL); Model Catalog: EVFTCL (Lot serial: ALL); Model Catalog: EVEC1 (Lot serial: ALL); Model Catalog: EVECL (Lot serial: ALL); Model Catalog: EVDBA1 (Lot serial: ALL); Model Catalog: EVPCA1 (Lot serial: ALL)
  • Product Description
    EDWARDS EV1000 SYSTEM - VOLUMEVIEW THERMODIULTION CABLE;EDWARDS EV1000 SYSTEM - BIFURCATED POWER SUPPLY;EDWARDS EV1000 SYSTEM - MONITOR;EDWARDS EV1000 SYSTEM - FLOTRAC CABLE;EDWARDS EV1000 SYSTEM - ETHERNET CABLE;EDWARDS EV1000 SYSTEM - POWER ADAPTER;EDWA
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.