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W.L. Gore is recalling GORE TAG stent grafts because the delivery catheter could not be withdrawn after implantation.
What this means for you
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an observed connection between the stent graft and the delivery catheter prevented the delivery catheter from being withdrawn when removal was attempted.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
- HighW L Gore Recalls Heparin Viabahn VBX Endoprosthesis Due to Packaging Defects
FDA (Devices) · 2024-09-11
Same hazard · mechanical failure
See all →- 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
- HighForest River Transit Buses Recalled for Wheelchair Lift Control Failure
NHTSA · 2026-09-01
- HighBlue Bird Recalls Vision School Buses Due to Wheelchair Lift Defect
NHTSA · 2026-08-31
- SevereMagic Tilt Watercraft Trailers Recalled Due to Winch Weld Failure
NHTSA · 2026-08-28