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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Arrow is recalling these products due to the possibility that the sheath body may become separated from the sheath hub. if the separation occurs there is a potential for bleeding from the device. if bleeding is not addressed with prompt intervention it may result in loss of significant blood volume or exsanguination. in addition delay of treatment interruption of treatment or loss of iab therapy can occur.