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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During inspection of product in its inventory sorin has identified that plastic flash may be present on the tip of the aortic arch cannulae. there is a risk that flash can become detached during cardiac surgery and be released into the patient's blood circulation resulting in the possibility of embolism. to mitigate this hazard sorin is removing these affected aortic arch cannulae from the marketplace and replacing them with new aortic cannulae which have been verified not to contain flash.