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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원인
Vascutek has recived two complaints whereby a small section of the delivery system sheath became detached from the collar during deployment of the anaconda longer leg iliac stent device from the delivery system. should this occur users should refer to the bailout procedure in the instructions for use (ifu) to complete the deployment.
Model Catalog: FL1223X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1221X170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1221X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1219X170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1219X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1217X170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1217X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1215X170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1215X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1213X170 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: FL1213X150 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: TL1210X170 (Lot serial: 2002380298); Model Catalog: TL1210X150 (Lot serial: 2002380298); Model Catalog: TL1210X170 (Lot serial: 2002233717); Model Catalog: TL1210X150 (Lot serial: 2002233717); Model Catalog: TL1210X170 (Lot serial: 2002224604); Model Catalog: TL1210X150 (Lot serial: 200222460
제품 설명
ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (FLARED);ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (TAPERED);ANACONDA LONGER LEG ILIAC STENT GRAFT SYSTEM (STRAIGHT)