Home / Recalls / W L Gore & Associates, Inc. / Z-0291-2021

Z-0291-2021 Class II Ongoing

Recalled by W L Gore & Associates, Inc. — Flagstaff, AZ

FDA device recall Z-0291-2021 was initiated by W L Gore & Associates, Inc. on September 9, 2020 and is designated Class II. 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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn. The recall status is ongoing. Affected quantity: 19013 units.

Recall Details

Product Type
Devices
Report Date
November 4, 2020
Initiation Date
September 9, 2020
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19013 units

Product Description

GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System

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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.

Distribution Pattern

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

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

Other recalls by W L Gore & Associates, Inc.

  • Z-2672-2026 Class II — GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (May 19, 2026)
  • Z-0036-2026 Class II — GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W (August 26, 2025)
  • Z-2945-2024 Class II — Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following (July 1, 2024)
  • Z-2946-2024 Class II — Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following (July 1, 2024)
  • Z-1048-2023 Class II — GORE CARDIOFORM Septal Occluder, REF: GSX0030A (December 14, 2022)
  • Z-0136-2023 Class II — GORE CARDIOFORM ASD Occluder. cardiovascular implant. (September 21, 2022)
  • Z-0077-2022 Class II — Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 (September 7, 2021)
  • Z-0169-2022 Class II — REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, C (September 2, 2021)
  • Z-0171-2022 Class II — REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, (September 2, 2021)
  • Z-0168-2022 Class II — REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, C (September 2, 2021)

FDA data resources