OFFICIAL-SOURCE RECALL · AUSTRALIA
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) Recall: Classification Class II Reason for the
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Why this product was recalled
Classification Class II Reason for the Action Following a request from the US FDA to update the Instructions for Use (IFU) for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) during its review of the TAMBE 2026 IDE Annual Report (G150071/R061) and PMA Annual Clinical Follow-Up Report (P230023/R006), Gore conducted an investigation into branch component occlusions. Review of ongoing clinical follow-up data identified additional branch component occlusions beyond those reported at the time of approval and indicated that smaller renal artery diameters (=5 mm) may be associated with reduced renal branch patency in certain patients. While no design or manufacturing deficiencies were identified, the IFU is being updated to provide additional information regarding branch component occlusions, associated clinical outcomes, long-term patency data, and anatomical factors that may influence branch performance Instructions for Customers/Users Customers are to: - Review the customer letter and enclosed Summary of IFU Changes, and ensure all relevant clinical and healthcare personnel are made aware of the updated information. - Carefully assess the benefit-risk profile of treatm
Hazard
Classification Class II Reason for the Action Following a request from the US FDA to update the Instructions for Use (IFU) for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE) during its review of the TAMBE 2026 IDE Annual Report (G150071/R061) and PMA Annual Clinical Follow-Up Report (P230023/R006), Gore conducted an investigation into branch component occlusions. Review of ongoing clinical follow-up data identified additional branch component occlusions beyond those reported at the time of approval and indicated that smaller renal artery diameters (=5 mm) may be associated with reduced renal branch patency in certain patients. While no design or manufacturing deficiencies were identified, the IFU is being updated to provide additional information regarding branch component occlusions, associated clinical outcomes, long-term patency data, and anatomical factors that may influence branch performance Instructions for Customers/Users Customers are to: - Review the customer letter and enclosed Summary of IFU Changes, and ensure all relevant clinical and healthcare personnel are made aware of the updated information. - Carefully assess the benefit-risk profile of treatm
Official recall notice
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)
Agency: Therapeutic Goods Administration
Official publication date: July 28, 2026
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