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 lifesciences is recalling the ep and scs01 coronary sinus catheters due to possible hemostasis valve displacement of the introcsc introducer component contained in packages of these products. if the valve becomes displaced there is an unlikely chance that the valve could be pushed through the sheath.