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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Livanova canada corp. (lnc) has identified a manufacturing issue affecting a limited number of perceval valves. these valves were shipped in a sterile packing solution that may contain higher than expected residual levels of homocysteic acid. the homocysteic acid is used during the manufacturing process to neutralize the free aldehydes introduced by the sterilization process.