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 Sep 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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.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: Nov 4, 2020
Initiation Date: Sep 9, 2020
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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-0291-2021
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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