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 has become aware of possible separation of the introducer sheath from the hub. the introducer (introcsc) is packaged with the endoplege coronary sinus catheter (ep). if the sheath becomes detached from the hub surgical intervention may be required to retrieve the sheath.