GORE VIABAHN VBX Balloon Expandable Endo BXB095902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132658824), received between Dec 17, 2025 and Sep 29, 2026 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 1, 2024Class IIOpen, Classified

   Due to packaging defects, sterility assurance and heparin activity may be compromised.

   Z-2945-2024 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Detachment of Device or Device Component

  Patient problems: Foreign Body In Patient

  MAUDE report 50937996 ↗
• InjuryJun 11, 2026Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). ON MAY 18, 2026, A TYPE 1C ENDOLEAK WAS IDENTIFIED IN THE SUPERIOR MESENTERIC ARTERY (SMA). ON (B)(6), 2026, AND A REINTERVENTION WAS PERFORMED EXTENDING THE SMA VBX DEVICE WITH A 7MM X 59MM VBX DEVICE.

  Patient problems: Clinical Endoleak

  MAUDE report 25479830 ↗
• MalfunctionApr 17, 2026Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, DURING AN ILIAC BRANCH ENDOPROSTHESIS (IBE) PROCEDURE A 12FR X 26CM GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) WAS USED TO ADVANCE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT) TO THE LEFT HYPOGASTRIC ARTERY. AS REPORTED, THERE WAS A PRE-EXISTING ENDURANT STENT AT THE INTENDED TREATMENT SITE. IT WAS REPORTED THE VBX STENT HAD TO BE RETRACTED BECAUSE THE WIRE AND SHEATH PROLAPSED INTO THE EXISTING EVAR DEVICE TO THE POINT THAT VBX STENT PUSHABILITY WAS LOST. AS THE VBX STENT WAS RETRACTED BACK INTO THE DSF, THE VBX STENT DISLODGED FROM THE BALLOON IN THE TRUNK OF THE EVAR DEVICE. THE PHYSICIAN WAS ABLE TO SNARE THE CONSTRAINED VBX STENT AND REMOVE IT FROM THE PATIENT WITH NO ISSUES. A NEW VBX DEVICE WAS ADVANCED AND DEPLOYED. THE PROCEDURE ENDED WITH GOOD OUTCOME. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24918031 ↗
• InjuryApr 3, 2026Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE VIA AAA 2401 TAMBE STUDY: ON (B)(6) 2025, A PATIENT UNDERWENT A THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE TO TREAT A DEGENERATIVE ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS, GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (AORTIC EXTENDER CONFORMABLE), AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). A VBX DEVICE WAS PLACED IN THE SUPERIOR MESENTERIC ARTERY, TWO IN THE RIGHT RENAL ARTERY, ONE IN THE CELIAC TRUNK, AND ONE IN THE LEFT RENAL ARTERY. A BOSTON SCIENTIFIC INNOVA¿ VASCULAR SELF-EXPANDING STENT SYSTEM WAS PLACED IN THE RIGHT RENAL ARTERY AS WELL. THERE WAS KNOWN HEAVY SCARRING/CALCIFICATION OF THE RIGHT GROIN PRIOR TO PROCEDURE WHICH WAS NEAR OCCLUSIVE (RIGHT FEMORAL ARTERY OCCLUSION) AND THE SUTURE BROKE DURING THE ACCESS CLOSURE AFTER DEVICE DEPLOYMENTS IN THE RIGHT GROIN REQUIRING THROMBECTOMY, ENDARTERECTOMY AND BOVINE PATCH WITH LARGE AMOUNT OF THROMBUS REMOVED. PHYSICIAN STATED THIS ADVERSE EVENT WAS RELATED TO DISEASE CONDITION. ON (B)(6) 2026, THE FOLLOW UP CTA SCAN SHOWED THERE WAS A SMALL LEFT SPLENIC INFARCT AND SMALL RIGHT RENAL INFARCT WHICH WERE RELATED TO TH

  Patient problems: Embolism/Embolus

  MAUDE report 24780150 ↗
• InjuryMar 13, 2026Complete Blockage; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT A THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. ON (B)(6) 2026, A REINTERVENTION WAS PERFORMED DUE TO STENOSIS AT THE DISTAL END OF THE VBX DEVICE IN THE SUPERIOR MESENTERIC ARTERY (SMA). A BARE METAL STENT (MEDTRONIC PROTEGE) WAS IMPLANTED. THE PHYSICIAN ATTRIBUTED THE STENOSIS TO VASCULITIS.

  Patient problems: Stenosis

  MAUDE report 24593566 ↗
• InjuryMar 6, 2026Partial Blockage

  THE FOLLOWING WAS OBTAINED FROM AAA 24-01 STUDY: ON (B)(6) 2026, A STUDY PATIENT UNDERWENT A THORACOABDOMINAL AORTA ANEURYSM (TAMBE) PROCEDURE. CUT-DOWN ACCESS WAS FROM THE LEFT SIDE. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. ON (B)(6) 2026, AS THERE WAS CONCERN OF POSSIBLE STENT THROMBOSIS, AN ANGIOGRAM WAS PERFORMED. ON (B)(6) 2026, DUE TO A ENDOLEAK TYPE 1C, A THROMBECTOMY AND STENT EXTENSION OF THE SUPERIOR MESENTERIC ARTERY WAS COMPLETED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24533522 ↗
• InjuryJan 9, 2026Device Stenosis

  ON (B)(6) 2025, THE PATIENT UNDERWENT A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE WHERE CONFORMABLE GORE® TAG® THORACIC STENT GRAFT (CTAG) AND FOUR GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE USED DURING THE PROCEDURE. IT WAS REPORTED DURING THE CASE, THE PHYSICIAN WAS UNABLE TO WIRE AND CANNULATE THE CELIAC ARTERY DUE TO TORTUOUS ANATOMY. AFTER AN EXTENSIVE AMOUNT OF TIME, THE PHYSICIAN DECIDED TO WIRE INSTEAD AND PLACE A VBX DEVICE IN THE SUPERIOR MESENTERIC ARTERY, RIGHT RENAL, AND THE LEFT RENAL. THE CELIAC PORTAL WAS EXTENDED WITH A VBX DEVICE AND AN 14MM AMPLATZ PLUG WAS PLACED INSIDE OF THE VBX DEVICE. ITS BELIEVED DURING THE CASE, POSSIBLY DUE TO POOR IMAGING AND VISUALIZATION OF THE CELIAC ARTERY, THE CTAG MAY HAVE BEEN COVERING THE ORIGIN. POSTOPERATIVELY THE PATIENT WAS DOING WELL.

  Patient problems: Reduced Blood Flow

  MAUDE report 24030200 ↗
• InjuryDec 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES. ON (B)(6) 2025, PATIENT UNDERWENT A REINTERVENTION PROCEDURE DUE TO AN ACCESS SITE HEMATOMA IN THE LEFT ARM. DURING THE INITIAL PROCEDURE THERE WAS A SURGICAL CUT DOWN PERFORMED TO DELIVER THE VBX DEVICES TO THEIR TARGET LOCATIONS. IT IS UNKNOWN WHAT CAUSED THE HEMATOMA, HOWEVER, IT IS THOUGHT TO BE UNRELATED TO THE GORE GRAFTS. DURING THE PROCEDURE THERE WAS IMAGING THAT SHOWED AN INDISCERNIBLE LEAK (TYPE AND LOCATION UNKNOWN) BUT PHYSICIAN THOUGHT IT IN THE SUPERIOR MESENTERIC ARTERY (SMA), SO WHILE THEY HAD ACCESS DURING THE HEMATOMA PROCEDURE, PHYSICIAN DECIDED TO ELECTIVELY IMPLANT AN ADDITIONAL VBX DEVICE AND EXTENDED THE SMA PORTAL OF THE TAMBE DEVICE. THE PATIENT TOLERATED PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 23827695 ↗

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