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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To inform customers that specific product code / lot number combinations may be at risk of having a balloon wall thickness that is higher than the required specification which could result in a slight increase in the force required to advance the balloon through the sheath and/or withdraw the balloon after inflation and deflation and could potentially lead to a slight prolongation of the procedure. potentially there may also be an increase in the balloon's non-compliance and rigidity. product return is not required.