Events

Recall of SWAN-GANZ CCO CATHETERS

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
    45105
  • Event Risk Class
    II
  • Event Initiated Date
    2010-04-27
  • 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 has received several confirmed complaints on the swan-ganz continuous cardiac output (cco) catheter products in which cardiac output measurements were unavailable and the following fault message was displayed in the vigilance monitors:"fault. cco catheter verification. use bolus mode."(instead of continuous output mode).

Device

SWAN-GANZ CCO CATHETERS
  • Model / Serial
    Model Catalog: 746HF8 (Lot serial: 58617339)
  • Product Description
    SWAN-GANZ CONTINUOUS CARDIAC OUTPUT (CCO) CATHETER
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.