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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Through post market surveillance data review edwards lifesciences has identified specific lots of the endoreturn arterial cannula that were built with an incorrect component. this component can create a performance problem with the intraclude intraaortic occlusion device.