FDA Device recall Z-0290-2021
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
- FDA Device
- Class II
- ongoing
- Published 2020-11-04
On 2020-11-04 the FDA classified a Class II recall of GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System by W L Gore And Associates, citing due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0290-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-09-09 |
| Published | 2020-11-04 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | W L Gore And Associates |
| Distribution | US |
Product
GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System
Reason
Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible
Identifiers
| code_info | CATALOG NUMBERS TGM212110X* TGM212115X* TGM212120X* TGM262610X* TGM262615X* TGM262620X* TGM282810X* TGM282815X*…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0290-2021%22
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