GORE TAG Stent Graft Recalled Due to Delivery Catheter Removal Issue
W.L. Gore is recalling GORE TAG stent grafts because the delivery catheter could not be withdrawn after implantation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk medical device where a mechanical failure (inability to remove the delivery catheter) poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
W.L. Gore & Associates, Inc. is recalling the GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System. The recall involves 19,013 units distributed nationwide in the United States and in numerous countries internationally, including Australia, Austria, Belgium, and the United Kingdom.
The recall was initiated because an observed connection between the stent graft and the delivery catheter prevented the delivery catheter from being withdrawn when removal was attempted. This issue occurred during the procedure when the catheter was being removed.
The source text does not specify the number of affected patients or report any specific injuries or illnesses. Consumers and healthcare providers should contact W.L. Gore & Associates, Inc. for further instructions regarding the recall and potential replacement or repair of the devices.
The recalled product
- Product
- GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
- Manufacturer
- W L Gore & Associates, Inc.
- Affected units
- 19,013
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Australia
- New Zealand
- J=Japan All Lot Numbers
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · W L Gore & Associates, Inc.
See all →- ModerateGORE VIABIL Biliary Endoprosthesis Recalled for Incorrect Labeling
FDA (Devices) · 2026-08-19
- ModerateGORE VIABIL Biliary Endoprosthesis Recalled for Incorrect Labeling
FDA (Devices) · 2026-08-19
- SevereGORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall
FDA (Devices) · 2026-07-08
- HighVascular grafts recalled after delamination reports prompt instructions for use update
FDA (Devices) · 2025-10-08
- HighHeparin Gore Viabahn VBX Endoprosthesis Recalled for Packaging Defects
FDA (Devices) · 2024-09-11
Same hazard · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- SevereGORE TAG CONFORMABLE Thoracic Stent Graft Recall for Deployment Issue
FDA (Devices) · 2020-11-04
- ModerateW L Gore Recalls 15 Thoracic Stent Grafts Due to Labeling Error
FDA (Devices) · 2020-05-27
- HighThoracic Stent-Graft System Recalled Due to Dimensional Defect
FDA (Devices) · 2023-01-25
- HighGORE TAG Thoracic Endoprosthesis Recalled for Incomplete Deployment Risk
FDA (Devices) · 2017-11-01
- ModerateMedtronic Recalls Thoracic Stent Grafts Due to Flushing Difficulty
FDA (Devices) · 2013-11-06
- SevereGORE TAG Thoracic Branch Endoprosthesis Side Branch Component Recall
FDA (Devices) · 2026-07-08