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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The combined actions of retracting the control collar while canting or attempting to retract the control collar when the device is already canted may lead to a system failure and could result in a loss of ability to re-position the device leading to a conversion to open surgical repair.
Model Catalog: B25 (Lot serial: ALL LOTS); Model Catalog: B23 (Lot serial: ALL LOTS); Model Catalog: B21 (Lot serial: ALL LOTS); Model Catalog: B19 (Lot serial: ALL LOTS); Model Catalog: B28 (Lot serial: ALL LOTS); Model Catalog: B30 (Lot serial: ALL LOTS); Model Catalog: B34 (Lot serial: ALL LOTS); Model Catalog: B32 (Lot serial: ALL LOTS)