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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There is an increase in "stuck in sheath" reports involving the use of the superarrowflex (wire-reinforced) sheath with the iab-058xx catheter series. when the iab becomes stuck in the sheath the user is unable to move the iab catheter forward or backward potentially causing a delay in this critical therapy.
Model Catalog: IAB-05830-LWS (Lot serial: All lots); Model Catalog: IAB-05840-LWS (Lot serial: All lots); Model Catalog: IAK-05845 (Lot serial: All lots); Model Catalog: IAB-05830-U (Lot serial: All lots); Model Catalog: IAB-05840-U (Lot serial: All lots)