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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The flexibility of the tip is limited since the hardened portion is too long which may lead to vessel damage during insertion. the root cause has been identified as an isolated manufacturing issue related to human error and is limited to the specified lot numbers.