GORE VIABAHN VBX Balloon Expandable Endo BXA107902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132637645), received between Jan 8, 2025 and Jul 27, 2026 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Complete Blockage” (1 report).

1 other recall cover devices cleared under the same FDA submission (P160021); 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.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Device Stenosis

  On (b)(6) 2025, a patient underwent endovascular repair of a thoracoabdominal aortic aneurysm utilizing a GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) system of components consisting of one aortic component, one thoracic component, one bifurcated component, one aortic extender, seven GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis devices, and three contralateral leg components. During the procedure, a VBX Device was delivered to the celiac trunk, navigated successfully to the intended location, deployed as intended, and implanted. Final completion angiography demonstrated that the device remained patent.On (b)(6) 2025, the patient was discharged.On (b)(6) 2026, the patient underwent computed tomography (CT) imaging follow-up. Evaluation demonstrated a patent aortic endograft and branch components with mild (<50%) stenosis of the celiac branch. No intervention or additional treatment was reported.

  Patient problems: Stenosis

  MAUDE report 50036827 ↗
• DeathMar 31, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: DURING A COVERED ENDOVASCULAR RECONSTRUCTION OF THE AORTIC BIFURCATION (CERAB) PROCEDURE ON (B)(6) 2026, ACCESS WAS MADE FROM THE FEMORAL ARTERIES. AN 11 X 29 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS DEPLOYED IN THE DISTAL AORTA WITH NO ISSUES. NEXT, 10 X 79 VBX DEVICES WERE IMPLANTED IN THE ILIAC ARTERIES USING A KISSING TECHNIQUE, INTO THE 11MM VBX DEVICE. AFTER DEPLOYMENT OF THE TWO 10MM VBX DEVICES, ANGIOGRAPHY REVEALED EXTRAVASATION IN THE LEFT LIMB. THE PATIENT'S BLOOD PRESSURE (BP) ALSO DROPPED, INDICATING A POTENTIAL PERFORATION NEAR THE DISTAL AORTA. THE SHEATHS (UNSPECIFIED BRAND/SIZE) USED TO ADVANCE THE VBX DEVICES WERE EXCHANGED TO A 12FR AND 16FR GORE® DRYSEAL FLEX INTRODUCER SHEATHS. THE VBX BALLOONS WERE PUSHED BACK UP INTO THE DISTAL AORTA IN ATTEMPTS TO STOP THE BLEEDING. AS REPORTED, THE PATIENT¿S BP STABILIZED, BUT WHEN BALLOONS WERE REMOVED, BP DROPPED. THE GORE® MOLDING & OCCLUSION BALLOON (MOB) WAS INSERTED IN THE LEFT LIMB. HOWEVER, THE MOB INADVERTENTLY PUSHED THE VBX STENT TOWARDS THE DISTAL AORTA. A 10 X 59 VBX DEVICE WAS IMPLANTED TO EXTEND THE 10 X 79 VBX DEVICE. AT THIS TIME, THE PATIENT'

  Patient problems: Extravasation; Vascular Dissection

  MAUDE report 24749999 ↗
• InjuryJan 8, 2025Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE UTILIZING THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) IN ZONE 5. PRIOR TO THE TAMBE PROCEDURE, THE PHYSICIAN ADDRESSED THE PATIENT'S LEFT RENAL ARTERY THAT WAS ALREADY OCCLUDED. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WAS DEPLOYED INTO THE RENAL PORTAL THAT WAS FOLLOWED BY AN AMPLATZER PLUG. DURING THE PROCEDURE, THERE WAS NOT AN ADEQUATE LANDING ZONE IN THE PATIENT¿S CELIAC ARTERY. THERE WAS A SHORT BRANCH FROM THE LEFT GASTRIC ARTERY THAT BRANCHED OFF THE SPLENIC ARTERY. TO ACHIEVE A SEAL INTO THE CELIAC ARTERY, THE PHYSICIAN PLUGGED THE SPLENIC ARTERY AND COILED THE LEFT GASTRIC ARTERY. A VBX DEVICE WAS THEN IMPLANTED INTO THE PATIENT¿S HEPATIC ARTERY. ADDITIONAL VBX DEVICES WERE IMPLANTED IN THE CELIAC ARTERY AND SUPERIOR MESENTERIC ARTERY WITH NO ISSUES. ON (B)(6), I-CAST STENT WAS IMPLANTED IN THE RIGHT RENAL ARTERY (RRA) DUE TO EXISTING HIGH-GRADE STENOSIS. DURING THE TAMBE PROCEDURE, TWO VBX DEVICES WERE DEPLOYED WITHIN THE RRA. AS REPORTED, PROCEDURE WENT SMOOTHLY AND THE PATIENT TOLERATED THE PROCEDURE. AFTER PROCEDUR

  Patient problems: Low Blood Pressure/ Hypotension; Thrombosis/Thrombus

  MAUDE report 21107680 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P160021. One submission often covers many models, so check the product and lot details in each record.

• Z-0077-2022 · Sep 7, 2021 · Open, Classified
  Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diame