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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Thomas medical products has recently become aware that in some instances the safesheath csg (coronary sinus guide) hemostatic introducer with radiopaque/soft tip may fracture during in vivo use resulting in device fragments that will remain in the patient's vasculature.