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.
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The return line air detector is being added as a precautionary measure because the manufacturer has received reports where excessive clotting (incident rate 0.009%) in the extracorporeal circuit resulted in air entering the return line.