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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Vascutek has received 3 complaints (with an occurrence rate of 0.1%) where the release wire of an anaconda body delivery system has fractured following stent deployment. two of these three incidents resulted in conversion to open repair. the manufacturer is recalling all anaconda bodies. previously implanted stents are not affected by this recall.
Model Catalog: B34 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: B32 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: B30 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: B19 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: B25 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: B23 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: B21 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: B28 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: OLB34 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: OLB32 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: OLB30 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: OLB21 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: OLB25 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: OLB23 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: OLB28 (Lot serial: >10 NUMBERS CONTACT MFR)