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 is a follow-up to previous field safety notices issued in june 2015 and october 2016. livanova has developed a solution to mitigate the dispersion of aerosols produced by the 3t heater-cooler (3t). the solution is a retrofit upgrade of devices currently in use at facilities and at livanova to reduce and mitigate potential risk of transmission of nontuberculous mycobacteria (ntm) due to aerosolization.