Events

Field Safety Notices about Conformable GORE® TAG® Thoracic Endoprosthesis

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by W.L. Gore and Asscociates, Inc..

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    1302
  • Date
    2017-10-20
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 data from the U.S. and the Czech Republic.
  • Extra notes in the data

Device

Conformable GORE® TAG® Thoracic Endoprosthesis
  • Model / Serial
    Model Number: TGE212110 TGE262610 TGE282810 TGE282815 TGE313110 TGE313115 TGE343410 TGE343415 TGE343420 TGE373710 TGE373715 TGE373720 TGE404010 TGE404015 TGE404020 TGE454510 TGE454515 TGE454520 TGE262110 TGE312610 TGE262610 TGE282810 TGE282815 TGE313110 TGE313115 TGE343410 TGE343415 TGE343420 TGE373710 TGE373715 TGE373720 TGE404010 TGE404015 TGE404020 TGE454510 TGE454515 TGE454520 TGE262110 TGE312610
  • Product Description
    Inactive implantable medical devices
  • Manufacturer
    W.L. Gore and Asscociates, Inc.

Manufacturer

W.L. Gore and Asscociates, Inc.