Z-0290-2021 Class II Ongoing
FDA device recall Z-0290-2021 was initiated by W L Gore & Associates, Inc. on Sep 9, 2020 and is designated Class II. Reason for recall: Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible The recall status is ongoing. Affected quantity: 13860 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 4, 2020
- Initiation Date
- Sep 9, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13860 units
Product Description
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
Reason for Recall
Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
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-0290-2021
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 25, 2026