Events

Recall of GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by W L Gore & Associates, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    78132
  • Event Risk Class
    Class 2
  • Event Number
    Z-0048-2018
  • Event Date Posted
    2017-10-25
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158746
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, endovascular graft, aortic aneurysm treatment - Product Code MIH
  • Reason
    Incomplete and/or partial deployment of the ctag device during the endovascular procedure.
  • Action
    The firm contact their consignee with a safety notice by letter on 09/25/2017. Gore is updating its Instructions for Use (IFU) to include the following new warnings and precautions: " If abnormal or inconsistent deployment line resistance is felt during deployment initiation, STOP deployment action immediately. If device remains constrained, remove device through the introducer sheath. If resistance is felt during removal through the sheath, stop and withdraw device and introducer sheath together. " If the device is in a partially deployed state and remains attached to the catheter, physicians should strongly consider conversion to immediate open surgical repair to avoid additional procedure time and potential harm from additional endovascular maneuvers.

Device

GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE
  • Model / Serial
    Serial Numbers: TGE212110 TGE212110 TGE212110K TGU212110 TGU212110H TGU212110B TGU212110J TGE262610 TGE262610 TGE262610K TGU262610 TGU262610H TGU262610B TGU262610J TGE282810 TGE282810 TGE282810K TGU282810 TGU282810H TGU282810B TGU282810J TGE282815 TGE282815 TGE282815K TGU282815 TGU282815H TGU282815B TGU282815J TGE313110 TGE313110 TGE313110K TGU313110 TGU313110H TGU313110B TGU313110J TGE313115 TGE313115 TGE313115K TGU313115 TGU313115H TGU313115B TGU313115J TGE343410 TGE343410 TGE343410K TGU343410 TGU343410H TGU343410B TGU343410J TGE343415 TGE343415 TGE343415K TGU343415 TGU343415H TGU343415B TGU343415J TGE343420 TGE343420 TGE343420K TGU343420 TGU343420H TGU343420B TGU343420J TGE373710 TGE373710 TGE373710K TGU373710 TGU373710H TGU373710B TGU373710J TGE373715 TGE373715 TGE373715K TGU373715 TGU373715H TGU373715B TGU373715J TGE373720 TGE373720 TGE373720K TGU373720 TGU373720H TGU373720B TGU373720J TGE404010 TGE404010 TGE404010K TGU404010 TGU404010H TGU404010B TGU404010J TGE404015 TGE404015 TGE404015K TGU404015 TGU404015H TGU404015B TGU404015J TGE404020 TGE404020 TGE404020K TGU404020 TGU404020H TGU404020B TGU404020J TGE454510 TGE454510 TGE454510K TGU454510 TGU454510H TGU454510B TGU454510J TGE454515 TGE454515 TGE454515K TGU454515 TGU454515H TGU454515B TGU454515J TGE454520 TGE454520 TGE454520K TGU454520 TGU454520H TGU454520B TGU454520J TGE262110 TGE262110 TGE262110K TGU262110 TGU262110H TGU262110B TGU262110J TGE312610 TGE312610 TGE312610K TGU312610 TGU312610H TGU312610B TGU312610J TGU212115J TGU212120J TGU262615J TGU262620J TGU282820J TGU313120J
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide.
  • Product Description
    GORE TAG, THORACIC ENDOPROSTHESIS, CONFORMABLE. || The GORE TAG Thoracic Endoprosthesis is intended || for endovascular repair of all lesions of the descending || thoracic aorta.
  • Manufacturer
    W L Gore & Associates, Inc.

Manufacturer

W L Gore & Associates, Inc.
  • Manufacturer Address
    W L Gore & Associates, Inc., 1500 N Fourth St., Flagstaff AZ 86003-2400
  • Manufacturer Parent Company (2017)
    W. L. Gore & Associates Inc.
  • Source
    USFDA