Events

Recall of COBE CMS 30-HVR BLOOD OXGENATOR WITH OPEN RESERVOIR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by LIVANOVA USA 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
    75502
  • Event Risk Class
    II
  • Event Initiated Date
    2001-06-27
  • 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
    Excessive amounts of defoaming agent resulting in significant degradation of performance.

Device

COBE CMS 30-HVR BLOOD OXGENATOR WITH OPEN RESERVOIR
  • Model / Serial
    Model Catalog: (Lot serial: 10C9600 04D9600)
  • Product Description
    cobe hvr 4000 reservoir
  • Manufacturer
    LIVANOVA USA INC.

Manufacturer

LIVANOVA USA INC.
  • Manufacturer Address
    ARVADA
  • Source
    HC