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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Edwards discovered that some of the valve jars containing the products may contain one or more small particles. the particles are metallic and were introduced into the valve jars during the packaging process. these particles are extremely small (vast majority <200 microns in size). if particles enter the body there is a risk that the particles can migrate.