GORE VIABAHN VBX Balloon Expandable Endo BXB067902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00733132658480), received between Feb 20, 2025 and May 19, 2026 — classified as 14 injuries.

The most frequently reported specific device problem is “Complete Blockage” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Deformation Due to Compressive Stress

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2026, THE PATIENT UNDERWENT A SUCCESSFUL THORACOABDOMINAL ENDOVASCULAR PROCEDURE AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) WAS IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) DEVICES WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. ON (B)(6), 2026, THE PATIENT PRESENTED WITH A LEFT LOWER QUADRANT ABDOMINAL PAIN WITH AN ONSET DATE OF APRIL 28. THE PATIENT REPORTED INCREASED FLATULENCE AND MORE FREQUENT BOWEL MOVEMENTS, THOUGH HIS LAST BOWEL MOVEMENT WAS NORMAL. THE PAIN RADIATED TO HIS GROIN AND BACK AND WAS ASSOCIATED WITH NAUSEA AND VOMITING. CTA IMAGING REVEALED AN OCCLUDED LEFT RENAL ARTERY WITH COMPRESSION OF THE VBX STENT. THE RIGHT RENAL ARTERY WAS PATENT, BUT ALSO HAD COMPRESSION OF THE VBX STENT. AN ANGIOGRAM WAS PERFORMED WITH THROMBECTOMY OF THE LEFT RENAL VBX STENT FOLLOWED BY PTA, STENTING AND POST-DILATATION. TREATMENT OF THE RIGHT RENAL VBX STENT FOLLOWED WITH PTA, STENTING, AND POST-DILATATION. IVUS WAS USED THROUGHOUT BOTH SIDES. BOTH VBX STENTS WERE RELINED WITH 6 MM X 60 MM PROTEGE STENTS. THE PROCEDURE WAS WELL TOLERATED AN

  Patient problems: Abdominal Pain

  MAUDE report 25219745 ↗
• InjuryMay 19, 2026Complete Blockage; Deformation Due to Compressive Stress

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT A SUCCESSFUL THORACOABDOMINAL ENDOVASCULAR PROCEDURE AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) WAS IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) DEVICES WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. ON (B)(6) 2026, THE PATIENT PRESENTED WITH A LEFT LOWER QUADRANT ABDOMINAL PAIN WITH AN ONSET DATE OF APRIL 28. THE PATIENT REPORTED INCREASED FLATULENCE AND MORE FREQUENT BOWEL MOVEMENTS, THOUGH HIS LAST BOWEL MOVEMENT WAS NORMAL. THE PAIN RADIATED TO HIS GROIN AND BACK AND WAS ASSOCIATED WITH NAUSEA AND VOMITING. CTA IMAGING REVEALED AN OCCLUDED LEFT RENAL ARTERY WITH COMPRESSION OF THE VBX STENT. THE RIGHT RENAL ARTERY WAS PATENT, BUT ALSO HAD COMPRESSION OF THE VBX STENT. AN ANGIOGRAM WAS PERFORMED WITH THROMBECTOMY OF THE LEFT RENAL VBX STENT FOLLOWED BY PTA, STENTING AND POST-DILATATION. TREATMENT OF THE RIGHT RENAL VBX STENT FOLLOWED WITH PTA, STENTING, AND POST-DILATATION. IVUS WAS USED THROUGHOUT BOTH SIDES. BOTH VBX STENTS WERE RELINED WITH 6 MM X 60 MM PROTEGE STENTS. THE PROCEDURE WAS WELL TOLERATED AND

  Patient problems: Abdominal Pain; Obstruction/Occlusion

  MAUDE report 25219448 ↗
• InjuryApr 28, 2026Complete Blockage

  THE FOLLOWING WAS REPORTED FROM A STUDY: ON (B)(6) 2026, A STUDY PATIENT UNDERWENT A THORACOABDOMINAL PROCEDURE AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICES WERE IMPLANTED. DURING THIS PROCEDURE, GORE® VIABAHN® VBX ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. ON (B)(6) 2026, THE PATIENT PRESENTED WITH NAUSEA, VOMITING, AND GENERALIZED WEAKNESS. CT ANGIOGRAPHY (CTA) SHOWED A NEW OCCLUSION OF THE LEFT RENAL ARTERY STENT AND CORRESPONDING PATCHY AREAS OF DECREASED RENAL ENHANCEMENT, AND CONCERNING FOR BILATERAL RENAL INFARCTS. CREATININE ON ADMISSION 1.69. BLADDER SCAN SHOWED MINIMAL URINE DESPITE IV FLUID ADMINISTRATION. LEFT RENAL ARTERY THROMBECTOMY WAS PERFORMED ON THE SAME DAY. THE PATIENT HAD ADEQUATE URINE OUTPUT POST-OPERATIVELY.

  Patient problems: Obstruction/Occlusion; Renal Impairment

  MAUDE report 25017606 ↗
• InjuryApr 21, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING THORACOABDOMINAL AORTIC ANEURYSM. DURING THE INDEX PROCEDURE, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED IN THE RIGHT RENAL ARTERY. DURING THE PROCEDURE, THE VBX DEVICE IN THE RIGHT RENAL ARTERY WAS DEPLOYED APPROXIMATELY 1 CM HIGHER THAN USUAL. THE VBX DEVICE WAS SUBSEQUENTLY RELINED WITH A COOK ZILVER STENT, EXTENDING MIDWAY WITHIN THE RENAL ARTERY PORTAL AND PROXIMALLY ABOVE THE AORTIC ORIGIN. ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION DUE TO OCCLUSION OF THE RIGHT RENAL ARTERY. DURING THIS PROCEDURE, THE RIGHT RENAL ARTERY WAS SUCCESSFULLY RE-CANNULATED, FOLLOWED BY THROMBECTOMY AND BALLOON ANGIOPLASTY.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24940912 ↗
• InjuryApr 15, 2026Partial Blockage

  THE FOLLOWING INFORMATION WAS REPORTED BY CLINICAL COMPLAINT SPECIALIST: 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. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2026, THE PATIENT PRESENTED WITH ABDOMINAL PAIN. ACUTE KIDNEY INJURY WAS IDENTIFIED. ON (B0(6) 2026, OCCLUSION WAS IDENTIFIED IN BOTH RIGHT AND LEFT RENAL ARTERIES. RENAL ARTERY INFARCT WAS NOTED IN BOTH RIGHT AND LEFT RENAL ARTERIES AND THE PATIENT WAS DISCHARGED. ON (B)(6) 2026, THE PATIENT PRESENTED WITH NAUSEA, VOMITING AND GENERAL WEAKNESS AND A THROMBECTOMY WAS PERFORMED IN THE RIGHT AND LEFT RENAL ARTERIES. ON (B)(6) 2026, A SPLENIC INFARCT WAS NOTED. THE CAUSE OF SPLENIC INFARCT WAS NOT RELATED TO ANY GORE DEVICE. NO TREATMENT WAS REQUIRED. THE PHYSICIAN IS MONITORING THE PATIENT.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24885284 ↗
• InjuryApr 8, 2026Complete Blockage

  THE FOLLOWING WAS REPORTED VIA AAA 24-01 STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT A PARARENAL ANEURYSM ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. IT WAS REPORTED THE PATIENT'S LEFT RENAL ARTERY WAS PLUGGED DURING THIS PROCEDURE. A PREPLANNED PROCEDURE WAS ALSO PERFORMED. A SELF-EXPANDING STENT GRAFT (UNKNOWN MANUFACTURER) WAS IMPLANTED IN THE PATIENT'S LEFT SUBCLAVIAN ARTERY. DURING PATIENT'S FOLLOW-UP ON (B)(6) 2026, CTA PERFORMED SHOWED THE RIGHT RENAL ARTERY WAS PATENT WITH NO STENOSIS PRESENT. ON (B)(6) 2026, THE PATIENT PRESENTED WITH AN OCCLUDED RIGHT RENAL ARTERY. AS REPORTED, INTERVENTION ATTEMPTS WERE MADE THE SAME DAY. ON (B)(6) 2026, THE PATIENT EXPIRED DUE TO CARDIAC ARREST FROM MULTISYSTEM ORGAN FAILURE. THE PHYSICIAN STATED THE VBX DEVICES DID NOT CONTRIBUTE TO THE PATIENT'S DEATH.

  Patient problems: Renal Impairment; Thrombosis/Thrombus

  MAUDE report 24823866 ↗
• InjuryFeb 26, 2026Partial Blockage

  THE FOLLOWING INFORMATION WAS RECEIVED FROM CLINICAL COMPLAINT SPECIALIST. 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. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED WITH THE TAMBE DEVICE. ON (B)(6) 2026, IT WAS REPORTED THAT THERE WAS CONCERN OF THROMBOSIS IN THE RENAL ARTERIES AS THE PATIENT WAS HAVING PAIN. ON (B)(6) 2026 A THROMBECTOMY WAS PERFORMED TO TO ADDRESS THE CONCERN OF THROMBOSIS IN THE RENAL ARTERIES. THE THROMBOSIS WAS RESOLVED WITHOUT SEQUELAE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24456937 ↗
• InjuryJan 29, 2026Obstruction of Flow

  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. THE PATIENT UNDERWENT REINTERVENTION ON (B)(6) 2025, FOR A THROMBOSED VBX DEVICE IN THE LEFT RENAL ARTERY. A PENUMBRA CLOT REMOVAL SYSTEM WAS USED, AND A BARE METAL STENT WAS PLACED IN THE LEFT RENAL ARTERY. THE PHYSICIAN ALSO NOTICED THE ANEURYSM HAD GROWN ROUGHLY 2 CM AND IT IS BELIEVED TO HAVE BEEN CAUSED BY A STILL PATENT CELIAC ARTERY.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24217757 ↗
• InjuryNov 24, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2025, THE PATIENT UNDERWENT A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE WHERE TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE RIGHT RENAL ARTERY. ONE IMPLANTED IN THE MOST PROXIMAL (WITHIN THE PORTAL) (LSN (B)(6)) AND ONE THE SECOND MOST PROXIMAL (LSN (B)(6)). AN ANGIOGRAPHY WAS PERFORMED AND ALL DEVICES WERE PATENT AND NO ENDOLEAKS WERE PRESENT. PATIENT DID NOT COMPLETE THEIR ONE MONTH VISIT. ON (B)(6) 2025, THE PATIENT PRESENTED WITH THROMBOSIS IN THE VBX DEVICE(S) IN THE RIGHT RENAL ARTERY. AT THIS TIME, THE THROMBOSIS HAS NOT BEEN RESOLVED AND IS ONGOING.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23639737 ↗
• InjurySep 16, 2025Complete Blockage; Obstruction of Flow; Complete Blockage; Obstruction of Flow

  ON (B)(6) 2025, THIS 82-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A JUXTARENAL ANEURYSM. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE), A GORE® EXCLUDER® AAA ENDOPROSTHESIS AND FOUR VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE SITES WERE ACCESSED PERCUTANEOUSLY. THERE WERE NO ADDITIONAL PROCEDURES. THERE WAS NO TYPE I OR TYPE III ENDOLEAKS NOTED AT THE END OF THE PROCEDURE. ON (B)(6) 2025, A LEFT RENAL ARTERY OCCLUSION WAS IDENTIFIED, REQUIRING HOSPITALIZATION AND TREATMENT. A REINTERVENTION INVOLVING THE TAMBE DEVICE OR ASSOCIATED STENTS WAS PERFORMED. ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR REINTERVENTION, INCLUDING PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), THROMBECTOMY, AND STENT GRAFT PLACEMENT TO ADDRESS THE TOTAL OCCLUSION OF THE LEFT RENAL ARTERY. FOLLOWING THE INTERVENTION, THE PATIENT RECOVERED WITHOUT SEQUELAE AS OF (B)(6) 2025.

  Patient problems: Reduced Blood Flow; Thrombosis/Thrombus

  MAUDE report 23066630 ↗
• InjurySep 3, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, THIS 61-YEAR-OLD FEMALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR MARFAN¿S SYNDROME; THE PROCEDURE INVOLVED THE AORTIC PATHOLOGY WITH BILATERAL ILIAC INVOLVEMENT. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND FOUR VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). THE SITES WERE ACCESSED BOTH PERCUTANEOUSLY AND BY CUT-DOWN. ON (B)(6) 2025, IT IS NOTED THE PATIENT HAS A RIGHT GROIN WOUND INFECTION. THIS IS NOTED TO BE PROCEDURE RELATED AND REQUIRED TREATMENT. THE IPSILATERAL FEMORAL ARTERY IS INVOLVED. ON (B)(6) 2025 THE PATIENT UNDERWENT A WASHOUT, WOUND VAC PLACEMENT, AND RECEIVED ANTIBIOTICS. NO FURTHER INFORMATION IS PROVIDED AT THIS TIME.

  Patient problems: Unspecified Infection

  MAUDE report 22958455 ↗
• InjuryAug 13, 2025Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF THE JUXTARENAL AORTIC ANEURYSM UTILIZING A 6 MM X 79 MM VBX DEVICE IN THE RIGHT RENAL ARTERY. ON (B)(6) 2025, PATIENT WAS PRESENTED WITH BILATERAL RENAL ARTERY STENT THROMBOSIS, APPROXIMATELY 10 MONTHS AFTER THE ENDOVASCULAR REPAIR OF THE JUXTARENAL AORTIC ANEURYSM. NO PREDISPOSING FACTOR AND PATIENT IS ON ACUTE RENAL FAILURE REQUIRING DIALYSIS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22798146 ↗
• InjuryMar 14, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE (GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS) WAS IMPLANTED TO TREAT AN ANEURYSM. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WERE IMPLANTED AS BRANCH DEVICES. TWO VBX DEVICES WERE IMPLANTED IN THE RIGHT RENAL ARTERY. ON (B)(6) 2025 POST-PROCEDURE, CT IMAGING SHOWED THROMBOSED VBX STENTS IN THE RIGHT RENAL ARTERY (RRA). DISTAL DISSECTION WAS ALSO NOTED. IMPLANTED MOST DISTALLY IN THE RRA WAS THE 6 X79 VBX STENT. AN INTERVENTION WAS PERFORMED. AFTER THE THROMBECTOMY, A BARE METAL STENT WAS IMPLANTED FOR A 2CM DISTAL EXTENSION. FOR RADIAL STRENGTH, THE EXISTING VBX STENTS WERE RELINED WITH IMPLANTATION OF A NEW 7X79 VBX DEVICE. AS REPORTED, THE CAUSE OF THROMBOSIS IS UNKNOWN; HOWEVER PHYSICIAN STATED THE OCCLUSION COULD BE RELATED TO THE RRA DISSECTION. THERE WERE NO ISSUES NOTED DURING THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 21610052 ↗
• InjuryFeb 20, 2025Difficult to Advance; Difficult to Advance

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THOROCOABDOMINAL ANEURYSM WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). DURING THE CANNULATION, THE PHYSICIAN HAD A VERY HARD TIME TRACKING A CATHETER INTO THE RENAL AND TRIED MULTIPLE DIFFERENT CATHETERS. AFTER THE INSERTION OF A VBX DEVICE INTO THE RENAL ARTERY A DISSECTION WAS IDENTIFIED. THE PHYSICIAN DECIDED TO COIL EMBOLIZE THE RENAL ARTERY LEADING TO COMPLETE KIDNEY LOSS. DUE TO THE COMPLICATION, THE PROCEDURE COULD NOT BE COMPLETED. THE PATIENT WILL RETURN TO THE OR ON (B)(6) 2025, TO COMPLETE THE PROCEDURE. PATIENT SYMPTOM CODE 2203, OTHER - USED TO CAPTURE LOSS OF KIDNEY FUNCTION.

  Patient problems: Renal Failure; Stenosis

  MAUDE report 21424942 ↗

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