Events

Recall of PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE

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
    44433
  • Event Risk Class
    III
  • Event Initiated Date
    2013-02-13
  • 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 identified an increase in reports of introducer leaks from the hemostasis valve while being used in conjunction with the proplege peripheral retrograde cardioplegia device. reports indicate that there have been cases where more blood loss than would be expected occurred.

Device

PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
  • Model / Serial
    Model Catalog: PR9 (Lot serial: 59385204); Model Catalog: PR9 (Lot serial: 59385164); Model Catalog: PR9 (Lot serial: 59398006); Model Catalog: PR9 (Lot serial: 59400402); Model Catalog: PR9 (Lot serial: 59398000); Model Catalog: PR9 (Lot serial: 59423199); Model Catalog: PR9 (Lot serial: 59385159); Model Catalog: PR9 (Lot serial: 59398008)
  • Product Description
    PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.

Manufacturer

EDWARDS LIFESCIENCES (CANADA) INC.