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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An inability to articulate the novaflex delivery system may lead to procedural complications including vessel perforation and potentially patient death. due to a change in manufacturing processes instituted at edwards in august 2010 there are reasonable grounds that all novaflex units manufactured after this date will function as intended. although it is believed the likelihood that other units have been impacted is very low edwards is recalling all novaflex delivery systems manufactured before august 2010 in order to eliminate this risk.