GORE VIABAHN VBX Balloon Expandable Endo BXA117901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132637751), received between Jul 27, 2019 and May 11, 2026 — classified as 1 death, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2020, THE PATIENT UNDERWENT A COVERED ENDOVASCULAR RECONSTRUCTION OF THE AORTIC BIFURCATION (CERAB) PROCEDURE USING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES. DURING THE PROCEDURE, VASCULAR ACCESS WAS OBTAINED VIA BILATERAL FEMORAL ARTERIES USING A PERCUTANEOUS APPROACH. IT WAS REPORTED, NO ACCESS CLOSURE DEVICE WAS UTILIZED; MANUAL PRESSURE WAS APPLIED. POSTOPERATIVELY, WHILE IN THE POST-ANESTHESIA CARE UNIT (PACU), THE PATIENT WAS NOTED TO HAVE AN EXPANDING RIGHT GROIN HEMATOMA, SUSPECTED TO BE DUE TO LACK OF HEMOSTASIS AT THE ARTERIAL PUNCTURE SITE. THE PATIENT WAS TAKEN BACK TO THE OPERATING ROOM FOR FURTHER MANAGEMENT. AN UNPLANNED SURGICAL CUTDOWN WAS PERFORMED WITH RIGHT GROIN EXPLORATION. THE HEMATOMA WAS SURGICALLY EVACUATED, AND THE ARTERY WAS REPAIRED WITH PRIMARY REPAIR. FOLLOWING THE PROCEDURE, THE GROIN HEMATOMA RESOLVED. ON (B)(6) 2020, THE PATIENT WAS DISCHARGED HOME.

  Patient problems: Hematoma

  MAUDE report 25143033 ↗
• InjuryAug 8, 2025Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE ON JUNE 26, 2025, FROM THE IMEDIDATA STUDY DATABASE: ON (B)(6) 2025, THIS 61-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A COMMON ILIAC ARTERY ANEURYSM. THIS WAS A REINTERVENTION OF A PRIOR ENDOVASCULAR PROCEDURE. IT IS UNKNOWN IF THE PRIOR ENDOVASCULAR PROCEDURE WAS A GORE® ENDOVASCULAR DEVICE. THE SITES WERE ACCESSED PERCUTANEOUSLY ON THE RIGHT. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT DEVICE IN THE RIGHT INTERNAL ILIAC ARTERY, A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE IN THE RIGHT INTERNAL ILIAC ARTERY, AND AN 11MM X 59MM GORE®VIABAHN®VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) IN THE RIGHT INTERNAL ILIAC ARTERY. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICE. THERE WERE NO ACCESS-RELATED COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) REVEALED OCCLUSION OF THE RIGHT EXTERNAL ILIAC ARTERY, INCLUDING ITS MORE DISTAL SEGMENT,

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22758577 ↗
• InjuryAug 7, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2025, THIS 61-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A COMMON ILIAC ARTERY ANEURYSM. THIS WAS A REINTERVENTION OF A PRIOR ENDOVASCULAR PROCEDURE. IT IS UNKNOWN IF THE PRIOR ENDOVASCULAR PROCEDURE WAS A GORE® ENDOVASCULAR DEVICE. THE SITES WERE ACCESSED PERCUTANEOUSLY ON THE RIGHT. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT DEVICE IN THE RIGHT INTERNAL ILIAC ARTERY, A GORE® EXCLUDER® AAA ENDOPROSTHESIS CONTRALATERAL LEG DEVICE IN THE RIGHT INTERNAL ILIAC ARTERY, AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) IN THE RIGHT INTERNAL ILIAC ARTERY. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND SUCCESSFULLY DEPLOYED. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICE. THERE WERE NO ACCESS-RELATED COMPLICATIONS. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6), 2025, THE PATIENT HAD THROMBOSIS OF THE RIGHT COMMON ILIAC ARTERY AND RIGHT EXTERNAL ILIAC ARTERY. ON (B)(6)2025, THE PATIENT UNDERWENT THROMBECTOMY WITH IMPLANT OF A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICE. THE O

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22742814 ↗
• MalfunctionSep 2, 2022Difficult or Delayed Positioning; Premature Separation; Difficult or Delayed Positioning; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT PRESENTED FOR AORTIC TREATMENT UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE THE VBX DEVICE WITHOUT PROTECTION (THE SHEATH SELECTED WAS TOO SHORT) TO THE AORTIC LESION, BUT IT FAILED TO CROSS. THE VBX DEVICE WAS THEN REMOVED FROM THE PATIENT. THE LESION WAS BALLOONED, AND THE VBX DEVICE WAS AGAIN ADVANCED WITHOUT SHEATH PROTECTION, BUT STILL COULD NOT CROSS THE TREATMENT SITE. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE VBX DEVICE BY PULLING IT BACK THROUGH THE SHEATH, THE STENT DISLODGED FROM THE BALLOON. THE PHYSICIAN WAS ABLE TO PUSH THE DISLODGED VBX DEVICE TO THE INTENDED TREATMENT SITE USING THE BALLOON CATHETER AND THEN SUCCESSFULLY DEPLOY THE VBX DEVICE OVER THE LESION. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352907 ↗
• DeathMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RETROPERITONEAL BLEED AFTER VBX KISSING STENTS PLACED IN DISTAL AORTA EXTENDING INTO BILATERAL COMMON ILIACS. VBX USED AS EXTENSIONS OF IBE DEVICE PLACED IN DISTAL AORTA FOR AORTO ILIAC OCCLUSIVE DISEASE. (AOID). AFTER INITIAL VBX INFLATION THE PLAQUE IN THE DISTAL AORTA WAS RUPTURED AND SUBSEQUENT BLOOD PRESSURE DROP WAS NOTICED WITH RETROPERITONEAL BLEED APPRECIATED ON ANGIOGRAM. ADDITIONAL PTA MEASURES WERE TAKEN AND BLEED AND BP STABILIZED AND PATIENT STABLE AND RECOVERED. ONCE PATIENT WAS ADMITTED TO HER ROOM AFTER THE PROCEDURE, A DROP IN HGB WAS NOTED AS WELL AS HYPERTENSION OVER NEXT 48 HOURS. 2 UNITS OF BLOOD GIVEN, HGB WENT FROM 8.1 TO 11. ACUTE RENAL FAILURE ALSO NOW DIAGNOSED AND 24HRS AFTER INDEX PROCEDURE THE PATIENT DEVELOPED ISCHEMIC BOWEL. PATIENT EXPIRED (B)(6) 2021. PHYSICIAN BELIEVES DEATH WAS PROCEDURE RELATED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 11455128 ↗
• MalfunctionJul 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, THE PATIENT UNDERWENT AORTOILIAC STENOSIS REPAIR USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) AND EXTEND INTO COMMON ILIAC WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE VBX MET SIGNIFICANT RESISTANCE PASSING THROUGH AN 8FR TERUMO SHEATH, BUT WAS EVENTUALLY IN PROPER POSITION AND SUCCESSFULLY DEPLOYED. WHEN REMOVING THE VBX BALLOON CATHETER THROUGH THE SAME SHEATH, WE AGAIN MET RESISTANCE EVEN WHILE PULLING NEGATIVE PRESSURE ON THE BALLOON. THE VBX CATHETER DETACHED INTO MULTIPLE PIECES. THE SHEATH AND CATHETER WERE PULLED OUT IN TANDEM, AND ANOTHER SHEATH WAS REINSERTED. THE PATIENT DID NOT APPEAR TO SUFFER AN ADVERSE EFFECT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10317398 ↗
• MalfunctionJul 27, 2019Difficult to Remove; Stretched; Patient-Device Incompatibility; Difficult to Remove; Stretched; Patient-Device Incompatibility

  AN UPDATE WAS RECEIVED THAT STATES AN 8 FR TERUMO INTRODUCER SHEATH WAS USED INSTEAD OF A 7FR DESTINATION SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8834439 ↗

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