GORE VIABAHN VBX Balloon Expandable Endo BXA115901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132637737), received between Feb 13, 2019 and Jun 22, 2026 — classified as 1 death, 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Deformation Due to Compressive Stress

  ON (B)(6) 2026, THE PATIENT UNDERWENT A COVERED ENDOVASCULAR RECONSTRUCTION OF THE AORTIC BIFURCATION (CERAB) PROCEDURE UTILIZING GORE® VIABAHN® VBX BALLOON-EXPANDABLE ENDOPROSTHESES (VBX DEVICES) DEVICES. DURING LESION PREPARATION, PRE-DILATION WAS PERFORMED USING A 7¿8 MM SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) DEVICE. THE BALLOON REPORTEDLY RUPTURED DURING USE, LIKELY DUE TO THE PRESENCE OF HEAVILY CALCIFIED STENOTIC DISEASE. THE VBX DEVICE DELIVERY SYSTEMS WERE ADVANCED VIA BILATERAL FEMORAL ACCESS SITES USING 7F AND 8F COOK FLEXOR ANSEL INTRODUCER SHEATHS OVER A 0.035" TERUMO GLIDEWIRE ADVANTAGE® HYDROPHILIC COATED GUIDEWIRE TO THE TARGET TREATMENT SITES. THREE ENDOPROSTHESES WERE SUCCESSFULLY DELIVERED AND DEPLOYED WITHOUT REPORTED COMPLICATIONS. THE 11 MM VBX DEVICE IN THE AORTA WAS POST-DILATED TO 16 MM TO OPTIMIZE APPOSITION. THE BILATERAL 8 MM ILIAC KISSING VBX STENTS WERE NOT POST-DILATED. ALL BALLOONS DEFLATED AS INTENDED, AND THE DELIVERY SYSTEMS WERE WITHDRAWN WITHOUT RESISTANCE OR BALLOON STICTION. INTRAVASCULAR ULTRASOUND (IVUS) DEMONSTRATED ADEQUATE EXPANSION AND LUMINAL PATENCY AT THE COMPLETION OF THE PROCEDURE. HEMOSTASIS WAS ACHIEVED USING A TERUMO ANGIO-SEAL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Wound Dehiscence

  MAUDE report 25578486 ↗
• MalfunctionApr 1, 2026Appropriate Device Problem Term/Code Not Available

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT IN AN INFRA-RENAL AORTA, A 12 X 30 MM SHOCKWAVE WAS USED. NEXT, AN 11 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS DEPLOYED ABOUT 1 CM PROXIMAL TO AORTIC BIFURCATION. THIS WAS CONFIRMED WITH IVUS. IT WAS REPORTED THE VBX STENT WAS DEPLOYED IN A CALCIFIED AORTA. DURING DEPLOYMENT, THE VBX DEVICE WAS INITIALLY INFLATED TO 6ATM DUE TO CLOSENESS OF THE AORTIC BIFURCATION. THE BALLOON WAS THEN ADVANCED 1CM PROXIMAL TO DISTAL EDGE OF THE VBX STENT AND TAKEN TO NOMINAL PRESSURE OF 10 AT WHICH POINT THE BALLOON RUPTURED. THE RUPTURED BALLOON WAS REMOVED FROM THE PATIENT WITH NO ISSUES. THE VBX STENT WAS POST DILATED WITH A 14X20MM ABBOTT ARMADA BALLOON. OPTIMUM RESULT WAS ACHIEVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. THE PHYSICIAN STATED THE ISSUE WAS LIKELY DUE TO THE CALCIFIED PLAQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24760889 ↗
• InjuryJul 26, 2025Partial Blockage; Partial Blockage

  THE FOLLOWING WAS REPORTED TO GORE ON JULY 8, 2025, FROM THE IMAGING DATABASE: THE FOLLOWING DESCRIPTION SUMMARY WAS PROVIDED FROM INFORMATION EXTRACTED FROM THE CSD BY THE CCS TEAM: ON (B)(6) 2025, THIS 68-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED ENDOVASCULAR PROCEDURE FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH TWO GORE® EXCLUDER® ENDOPROSTHESIS DEVICES AND THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATIONS AND SUCCESSFULLY DEPLOYED. THE SITES WERE ACCESSED PERCUTANEOUSLY. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, IT WAS NOTED THE PATIENT HAD A CTA. THERE IS NO LOSS OF PATENCY NOTED. IT IS NOTED BY IMAGINING THAT THERE IS DEVICE INFOLDING OR COMPRESSION OF THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBC). IT IS ALSO NOTED THAT THERE IS MILD THROMBUS PRESENT IN THE VBX DEVICES IN THE RCI AND RIIA. 2203-A: -OTHER USED TO CAPTURE THROMBOSIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22621523 ↗
• MalfunctionMar 7, 2025Deformation Due to Compressive Stress; Deformation Due to Compressive Stress

  A STUDY ALERT FROM THE TGR 23-02 AAA CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR AN AORTO-ILIAC ANEURYSM PROCEDURE. DURING THIS PROCEDURE, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WAS IMPLANTED IN THE RIGHT HYPOGASTRIC ARTERY. ON (B)(6) 2024, THE PATIENT HAD A FOLLOW-UP AND CTA IMAGING SHOWED A VBX STENT COMPRESSION OF THE RIGHT HYPOGASTRIC ARTERY DEVICE. NO INTERVENTION WAS REPORTED.

  Patient problems: Stenosis

  MAUDE report 21552215 ↗
• InjuryAug 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, A PATIENT UNDERWENT A REVISION PROCEDURE IN THE RIGHT ARM (WITH SEVERE EDEMA) TO TREAT CENTRAL VENOUS STENOSIS IN A BRACHIOCEPHALIC ARTERIOVENOUS (AV) FISTULA USING AN 11 MM X 59 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT VIA THE RIGHT UPPER ARM BY MAKING A MICRO PUNCTURE AND THEN USING AN 8F SHEATH (BRAND UNKNOWN) OVER AN .035"GUIDEWIRE (BRAND UNKNOWN). REPORTEDLY, IT WAS TIGHT GOING THROUGH THE SHEATH, BUT THE DELIVERY CATHETER DID ADVANCE TO THE TARGET LOCATION. AT THE TARGET TREATMENT SITE BEFORE DEPLOYMENT, IT WAS DETERMINED THE ENDOPROSTHESIS WAS TOO LONG. THE DECISION WAS MADE TO WITHDRAW THE DELIVERY SYSTEM TO USE A DIFFERENT SIZE ENDOPROSTHESIS. THE DELIVERY CATHETER WAS WITHDRAWN BACK THROUGH THE SHEATH. A 10 MM X 29 MM VBX DEVICE WAS SELECTED AS A REPLACEMENT. AS THE DELIVERY CATHETER WAS BEING ADVANCED, THEY NOTICED ON FLUOROSCOPY THAT THE 11 MM X 59 MM ENDOPROSTHESIS HAD DISLODGED FROM THE DELIVERY CATHETER, AND WAS STILL IN THE TARGET LOCATION ON THE GUIDEWIRE. IT WAS FURTHER OBSERVED THAT THE DISLODGED ENDOPROSTHESIS TRAVELED FROM THE SUBCLAVIAN VEIN TO THE HEART, OUT THROUG

  Patient problems: Insufficient Information

  MAUDE report 20037537 ↗
• MalfunctionJun 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON JUNE 14, 2023, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE LEFT COMMON ILIAC ARTERY DURING TREATMENT OF A SEVERELY CALCIFIED LESION. THE PHYSICIAN GAINED ACCESS FROM THE LEFT SUPERFICIAL FEMORAL ARTERY AND ADVANCED AN 0.035" ROSEN GUIDE WIRE ACROSS THE CALCIFIED LESION. HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE A TERUMO DESTINATION GUIDING SHEATH (SIZE UNKNOWN) THROUGH THE CALCIFICATION. AFTER MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE VBX DEVICE ACROSS THE CALCIFIED LESION, THE VBX DEVICE HAD BECOME DISLODGED FROM THE DELIVERY CATHETER. THE PHYSICIAN MADE THE DECISION TO REMOVE THE VBX DELIVERY CATHETER, ADVANCE A 4MM BALLOON (MANUFACTURER UNKNOWN) AND INFLATE THE DEVICE WHERE IT WAS. THE PHYSICIAN ADVANCED AN 8MM BALLOON (UNKNOWN MANUFACTURER) TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 17136773 ↗
• DeathJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023 BILATERAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED IN THE LEFT AND RIGHT COMMON ILIAC ARTERIES TO TREAT AN AORTOILIAC ANEURYSM. THE PHYSICIAN INITIATED THE PROCEDURE WITH ENDOVASCULAR LITHOTRIPSY BILATERALLY IN THE RIGHT AND LEFT COMMON ILIAC ARTERIES WITH A SHOCKWAVE DEVICE. THE VBX DEVICES WERE IMPLANTED WITHOUT DIFFICULTY OR COMPLICATIONS. AFTER POST DILATION A FINAL CTA WAS RUN THAT INDICATED A BLEED IN THE AORTA. AT THAT TIME A GORE® EXCLUDER®AAA ENDOPROSTHESIS WAS IMPLANTED FOR A ZONE 9 INFRARENAL DISSECTION. IT IS UNKNOWN WHAT EVENTS LED TO AN OPEN PROCEDURE AFTER THE GORE® EXCLUDER®AAA ENDOPROSTHESIS WAS IMPLANTED. THE PATIENT EXPIRED ON (B)(6) 2023 AT 8:50PM. MORE INFORMATION IS BEING OBTAINED INCLUDING IF THE PATIENT'S CAUSE DEATH WAS GORE DEVICE RELATED.

  Patient problems: Vascular Dissection

  MAUDE report 17112789 ↗
• InjuryAug 10, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS TO BE PLACED FOR TREATMENT OF STENOSIS IN THE COMMON ILIAC ARTERY. HOWEVER, THE PHYSICIAN COULD NOT CROSS THE LESION AND WHEN THE PHYSICIAN WAS REMOVING THE DEVICE THOUGH A BOSTON SCIENTIFIC SHEATH, THE DEVICE HAD BECOME DISLODGED FROM THE CATHETER. THE PHYSICIAN THEN HAD TO PERFORM A CUT DOWN TO THE VESSEL AND REMOVE THE DEVICE. AN ADDITIONAL VBX DEVICE WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.

  Patient problems: No Code Available

  MAUDE report 10388858 ↗
• MalfunctionMay 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF UNKNOWN TYPE/LOCATION WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. REPORTEDLY THE DEVICE WAS ADVANCED JUST PAST THE SHEATH WHEN THE DELIVERY CATHETER BROKE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8618162 ↗
• MalfunctionFeb 20, 2019Separation Problem; Separation Problem

  THE FOLLOWING WAS REPORTED TO GORE: A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WITH HEPARIN WAS INSERTED INTO AN 8FR SHEATH WITHOUT ISSUE. THE DEVICE WAS INFLATED AND THE STENT DEPLOYED WITHOUT ISSUE. THE BALLOON WAS DEFLATED AND PULLED BACK TO REMOVE FROM PATIENT. THE PHYSICIAN MET SIGNIFICANT RESISTANCE TRYING TO REMOVE THE CATHETER FROM THE PATIENT. DURING THIS RESISTANCE THE CATHETER HUB DISLODGED FROM THE CATHETER. THE WIRE AND CATHETER WERE REMOVED WITH NO FURTHER ISSUES.

  Patient problems: No Information

  MAUDE report 8356399 ↗
• MalfunctionFeb 13, 2019Detachment of Device or Device Component; Premature Separation; Detachment of Device or Device Component; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: AAA ANEURYSM & RIGHT COMMON ILIAC ANEURYSM; DOCTOR SCRUNCHED THE PROXIMAL END OF THE PREVIOUSLY PLANTED GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS SO WAS ATTEMPTING TO REPAIR THE SCRUNCH; GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS ATTEMPTED TO BE ADVANCED TO TARGET AREA; UNABLE TO ADVANCE TO THE TARGET AREA, THE DOCTOR DECIDED TO REMOVE THE DEVICE; DEVICE GOT STUCK DURING WITHDRAWAL SO DOCTOR DECIDED TO PULL HARD; STENT SEPARATED FROM THE CATHETER; DOCTOR ADVANCED AN ICAST AND PINNED THE UNDEPLOYED GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS TO THE VESSEL WALL.

  Patient problems: Aneurysm

  MAUDE report 8337645 ↗

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