Events

Recall of CRYOPRESERVED CARDIAC ALLOGRAFT

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by HOSPITAL FOR SICK CHILDREN.

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
    23431
  • Event Risk Class
    III
  • Event Initiated Date
    2013-10-18
  • 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
    *not for web posting* patient that developed a renal tumour received a kidney graft from the same donor that the aortic valve was retrieved from.

Device

CRYOPRESERVED CARDIAC ALLOGRAFT
  • Model / Serial
    Model Catalog: AORTIC VALVE (Lot serial: 02279)
  • Product Description
    *NOT FOR WEB POSTING* CRYOPRESERVED CARDIAC ALLOGRAFT - AORTIC VALVE ALLOGRAFT
  • Manufacturer
    HOSPITAL FOR SICK CHILDREN

Manufacturer

HOSPITAL FOR SICK CHILDREN