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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This recall has been initiated due to reported issues of hoops failing to close when the device was actuated. in some cases this issue has been discovered in-use. there is the possibility that a malfunctioning device could damage the vessel upon withdrawal.