Events

Recall of GORE TAG THORACIC ENDOPROSTHESIS

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by W L Gore & Assoc, 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
    35507
  • Event Risk Class
    Class 2
  • Event Number
    Z-1237-06
  • Event Initiated Date
    2006-04-28
  • Event Date Posted
    2006-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-13
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=46281
  • 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
    Two lots of uniquely different product were switched and mislabeled with the wrong length. 34mm x 10cm devices were mislabeled as 34mm x 15cm and vice versa.
  • Action
    All the letters were sent via Federal Express to each Gore Field Sales Associate (FSA) to be hand-delivered to the Physician and to the hospital Risk Manager. A cover note to the FSA directing them regarding the hand delivery of the letter. Also included is a memo to the FSA with a document that the FSA is directed to complete, sign/date and return to Gore documenting hand-delivery of each of these letters. These letters were to be hand delivered on 18 May, or 19 May, 2006.

Device

GORE TAG THORACIC ENDOPROSTHESIS
  • Model / Serial
    Lot numbers: 04150272, 04150273, 04150274, 04150275, 04150276, 04150277, 04150278, 04150279, 04150280, & 04150281
  • Product Classification
    Cardiovascular Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Nationwide to: AL, CT, KS, MA, & MN
  • Product Description
    GORE TAG THORACIC ENDOPROSTHESIS System, Endovascular Graft, Aortic Aneurysm Treatment, Catalogue Number TG3415, 34mm x 15cm
  • Manufacturer
    W L Gore & Assoc, Inc.

Manufacturer

W L Gore & Assoc, Inc.
  • Manufacturer Address
    W L Gore & Assoc, Inc., 1500 N. Fourth St, Flagstaff AZ 86001
  • Source
    USFDA