FDA Device recall Z-0291-2021
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 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 fro….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0291-2021 |
| 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
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observed connection between the stent graft and the delivery catheter that prevented the delivery catheter from being withdrawn.
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-0291-2021%22
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