Class 2 Device Recall GORE TAG Conformable Thoracic Stent Graft with ACTIVE

• Date Initiated by Firm: September 09, 2020
• Create Date: October 23, 2020
• Recall Status: Open, Classified
• Recall Number: Z-0291-2021
• Recall Event ID: 86421
• PMA Number: P040043
• Product Classification: System, endovascular graft, aortic aneurysm treatment - Product Code MIH
• Product: GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
• Code Information: CATALOG NUMBERS TGM212110X* TGM212115X* TGM212120X* TGM262610X* TGM262615X* TGM262620X* TGM282810X* TGM282815X* TGM282820X* TGM313110X* TGM313115X* TGM313120X* TGM343410X* TGM343415X* TGM343420X* TGM373710X* TGM373715X* TGM373720X* TGM404010X* TGM404015X* TGM404020X* TGM454510X* TGM454515X* TGM454520X* TGM262110X* TGM312610X* TGMR313110X* TGMR313115X* TGMR313120X* TGMR312610X* TGMR373710X* TGMR373715X* TGMR373720X* TGMR404010X* TGMR404015X* TGMR404020X* *X is a placeholder for enumeration code: E=EMEA, Australia, New Zealand; J=Japan All Lot Numbers
• Recalling Firm/ Manufacturer: W L Gore & Associates, Inc.; 3750 W Kiltie Ln; Flagstaff AZ 86005-8712
• For Additional Information Contact: 800-528-8763
• Manufacturer Reason for Recall: When the delivery catheter was attempted to be removed, there was an observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
• FDA Determined Cause: Process control
• Action: On 09/23/2020, the firm sent an "URGENT Medical Device Safety Correction" via First Class Postal (USPS) informing them that all lots of its Thoracic Stent Graft Systems may encounter difficulty withdrawing the delivery catheter due to a proximal stent apex being lodged with the delivery catheter leading olive. Customers are instructed to: Immediate Actions for the Recipient: - Take note of amendment/reinforcement of Instructions For Use (IFU) - Please respond to the enclosed acknowledgement - Please share this letter with others in your hospital or clinic as appropriate The Recalling Firm is providing physicians with this information so that appropriate risk-related decisions can be made with the patient when considering the Conformable Thoracic Stent Graft System. The Recalling Firm maintains its confidence in the safety and efficacy of the device and will not be removing the affected products from the market. There are no actions required for patients already implanted with the Thoracic Stent Graft. Please contact the Recalling Firm's Customer Service (email: MPDCustomerCare@wlgore.com or by phone at 800-528-8763) with any questions related to this letter.
• Quantity in Commerce: 19013 units
• Distribution: U.S. - Nationwide O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• PMA Database: PMAs with Product Code = MIH and Original Applicant = W. L. GORE & ASSOCIATES, INC.