GORE TAG Thoracic Branch Endoprosthesis TAC124520ARecalls & reported problems

W. L. Gore & Associates, Inc. · TAG TBE AORTIC COMPONENT TAC TBE AC 12MMX45MMX20CM · Class 3 · Implant

All models of GORE TAG Thoracic Branch Endoprosthesis (30)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132654260), received between Sep 12, 2025 and Sep 12, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Device Endoleak” (1 report).

1 other recall cover devices cleared under the same FDA submission (P210032); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Device Endoleak1

Patient problems

Clinical Endoleak1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjurySep 12, 2025Device Endoleak; Device Endoleak
THE FIELD SALES ASSOCIATE (FSA) REPORTED THE FOLLOWING TO GORE: ON AN UNSPECIFIED DATE, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC). ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED TO ADDRESS A TYPE 1A ENDOLEAK, UTILIZING THE GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC) AND GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, IT WAS NOTED THAT THE TYPE 1A ENDOLEAK DID NOT RESOLVE. THE PHYSICIAN PLANS TO PERFORM AN ADDITIONAL REINTERVENTION TO IMPLANT AN AORTIC EXTENDER. ON (B)(6) 2025, THE REINTERVENTION WAS PERFORMED. AN AORTIC EXTENDER WAS IMPLANTED. THE PATIENT TOLERATED THE PROCEDURE.
Patient problems: Clinical Endoleak
MAUDE report 23038911 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P210032. One submission often covers many models, so check the product and lot details in each record.

Z-2672-2026 · May 19, 2026 · Open, Classified
GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB08

Device details

UDI-DI	`00733132654260`
Brand	GORE TAG Thoracic Branch Endoprosthesis
Model	TAC124520A
Company	W. L. Gore & Associates, Inc.
Product code	MIH · System, Endovascular Graft, Aortic Aneurysm Treatment
Class	Class 3
FDA submission	P210032
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Conditional
Status	In Commercial Distribution
Record updated	Aug 29, 2023

Device type (GMDN): Aortic arch endovascular stent-graft

A non-bioabsorbable tubular device intended for endovascular implantation, in a modular configuration, to repair lesions of the aortic arch and descending thoracic aorta. It is typically made of a metal alloy [e.g., nickel-titanium alloy (Nitinol)] that forms an outer mesh structure with an inner synthetic polymer tube (endovascular graft). It includes a docking portal(s) for attachment of an ancillary endovascular stent-graft(s) [not included] to occupy and allow flow to an aortic arch branch vessel(s). It is percutaneously inserted via the femoral artery to the site of implantation and expanded in situ; disposable devices associated with implantation may be included.

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All System, Endovascular Graft, Aortic Aneurysm Treatment devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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