GORE VIABAHN VBX Balloon Expandable Endo BXA113902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132637720), received between Mar 1, 2021 and Jan 8, 2026 — classified as 2 deaths, 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WITH A BOVINE ARCH UNDERWENT A PROCEDURE. ACCESS WAS MADE FROM THE RIGHT CAROTID ARTERY FOR ADVANCEMENT OF THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) THAT WAS INTENDED TO STOP BLOOD FLOW INTO THE INNOMINATE ARTERY. WHEN THE VBX DEVICE REACHED THE TARGET TREATMENT, BUT THE VBX DEVICE WAS UNABLE TO MANEUVER THE TURN OF THE VESSEL. THE VBX DEVICE WAS BEING PULLED BACK INTO SHEATH WHEN THE VBX STENT CAUGHT ON THE SHEATH EDGE AND DISLODGED. BRACHIAL ACCESS WAS MADE TO ACCOMMODATE THRU & THRU WIRES THAT WERE USED A A 'RAIL'. THE PHYSICIAN WAS ABLE TO MOVE THE VBX STENT INTO THE TARGET LOCATION AND DEPLOYMENT WAS STARTED WITH A 3MM BALLOON. LARGER BALLOONS WERE THEN USED TO ACHIEVE FULL DEPLOYMENT. AS REPORTED, THE PATIENT IS RECOVERING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24005301 ↗
• MalfunctionMay 6, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT A REINTERVENTION PROCEDURE TO TREAT A TYPE 1B ENDOLEAK OF A PREVIOUSLY IMPLANTED MEDTRONIC STENT GRAFT USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) ILIAC BRANCH COMPONENT, AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES IN THE LEFT INTERNAL ILIAC ARTERY. IT WAS REPORTED, AN 11 MM X 39 MM VBX DEVICE WAS ADVANCED WITHOUT RESISTANCE TO THE INTERNAL ILIAC ARTERY. DURING DEPLOYMENT, FOR AN UNKNOWN REASON, IT APPEARED THAT THE DELIVERY SYSTEM BALLOON WAS NOT INFLATING AS EXPECTED (EVEN AT MAXIMUM ATM), AND THE ENDOPROSTHESIS ONLY PARTIALLY EXPANDED. THE DELIVERY BALLOON WAS DEFLATED AND REINFLATED, WHICH SUCCESSFULLY EXPANDED THE ENDOPROSTHESIS TO THE DESIRED DIAMETER. REPORTEDLY, DURING WITHDRAWAL OF THE DELIVERY CATHETER, MINIMAL RESISTANCE WAS NOTICED, HOWEVER THE DELIVERY CATHETER SNAPPED WHILE INSIDE THE PATIENT. THE BROKEN CATHETER WAS ON THE GUIDEWIRE INSIDE THE INTRODUCER SHEATH. THE DECISION WAS MADE TO WITHDRAW THE ENTIRE SYSTEM IN TANDEM FROM THE PATIENT. THE BROKEN CATHETER (WITH THE BALLOON STILL ATTACHED) WAS REMOVED SUCCESSFULLY. REPORTEDLY, UP AND OVER ACCESS

  Patient problems: Insufficient Information

  MAUDE report 21972328 ↗
• InjuryMay 1, 2025Migration; Migration

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON AN UNKNOWN DATE THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH STAB WOUNDS TO NECK AND CHEST. ON (B)(6) 2025, THE PATIENT PRESENTED WITH A PSEUDOANEURYSM IN THE BRACHIAL ARTERY AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED. ON (B)(6) 2025, LESS THEN 24 HOURS AFTER THE DEVICE WAS IMPLANTED, THE PATIENT RETURNED TO THE EMERGENCY ROOM WITH CHEST PAIN AND THE VBX DEVICE WAS OBSERVED TO HAVE MIGRATED INTO THE LOWER AORTA. THE PHYSICIAN USED A SNARE TO REMOVE THE VBX DEVICE AND SUCCESSFULLY IMPLANTED TWO ADDITIONAL VBX DEVICES TO TREAT THE PSEUDOANEURYSM. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Chest Pain; Pseudoaneurysm

  MAUDE report 21942188 ↗
• InjuryOct 16, 2023Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2023, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH A GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM (CTAGAC) IN THE LEFT COMMON CAROTID (LCC) ARTERY TO TREAT A TYPE B DISSECTION WITH MALPERFUSION. THE CTAGAC WAS IMPLANTED TO THE LEVEL OF THE LCC AND AN 11MM X 39MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT) WAS IMPLANTED IN THE LEFT SUBCLAVIAN ARTERY (LSA). THE FENESTRATION AND THE TYPE B DISSECTION WERE RESOLVED; THE FALSE LUMEN WAS NOT PRESSURIZED. PATIENT TOLERATED THE PROCEDURE. ON (B)(6), 2023, AN REINTERVENTION WAS PERFORMED DUE TO A TYPE 1A ENDOLEAK INTO THE FENESTRATION. THE ENDOLEAK WAS BETWEEN THE LSA WITH VBX STENT AND THE PREVIOUS CTAGAC IN THE DESCENDING AORTA. THE LEAK WAS FROM AROUND THE CTAGAC AND IT APPEARED THE VBX STENT HAD PULLED OUT OF THE LSA. THREE VBX STENTS WERE IMPLANTED, THEN A GORE® EXCLUDER® AAA ENDOPROSTHESIS WAS DEPLOYED TO EXTEND FURTHER DISTALLY INTO THE LSA. THE INTERVENTION WAS CONCLUDED, AND PATIENT STILL HAD RESIDUAL TYPE 1A ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 17946407 ↗
• InjuryJul 27, 2023Material Fragmentation; Off-Label Use; Material Fragmentation; Off-Label Use

  ON (B)(6) 2022, THE PATIENT WITH SMALL BOWEL MOTILITY ISSUES UNDERWENT TREATMENT IN THE SUPERIOR VENA CAVA (SVC) WHERE AN 11 MM X 39 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS PLACED AS A CONDUIT FOR CATHETER ACCESS USED DURING ADMINISTRATION OF TOTAL PARENTERAL NUTRITION (TPN). REPORTEDLY, THE PHYSICIAN HAS USED THE VBX DEVICE IN THIS MANNER 4-5 TIMES PREVIOUSLY. THEY SELECTED THE BIGGEST DIAMETER VBX DEVICE THEY COULD; LENGTH DID NOT NEED TO BE LONG. THE VBX DEVICE WAS NOT POST-DILATED AFTER PLACEMENT. THEY WERE NOT CONCERNED ABOUT WALL APPOSITION BECAUSE THE SVC WAS OCCLUDED, AND THEY FELT THE VBX DEVICE WAS NOT GOING TO MOVE. ON (B)(6) 2023, THE PATIENT WAS HAVING A NON-STENT RELATED ECHOCARDIOGRAM FOR BACTEREMIA WHEN THERE WAS AN INCIDENTAL FINDING OF STENT-GRAFT MATERIAL LOCATED IN THE HEART. A CHEST X-RAY WAS THEN PERFORMED AND ADDITIONAL PIECES OF STENT-GRAFT MATERIAL WAS FOUND IN THE LUNG. THIS PIECE LOOKED LIKE THREE OF THE STAINLESS STEEL "DIAMONDS". IT IS UNKNOWN IF THERE WAS EPTFE AS WELL. THE X-RAY ALSO SHOWED THE PROXIMAL AND DISTAL PORTIONS OF THE VBX DEVICE WERE STILL LOCATED IN THE SVC. THE FRACTURED PART OF THE STENT-GRAFT WAS LOCATE

  Patient problems: Foreign Body In Patient

  MAUDE report 17410267 ↗
• 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 17112707 ↗
• DeathAug 17, 2021Device-Device Incompatibility; Device-Device Incompatibility

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AORTIC OCCLUSIVE DISEASE AND WAS IMPLANTED WITH GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESES. THE TRUNK IPSILATERAL LEG COMPONENT DEPLOYED CORRECTLY BUT WAS POSITIONED SLIGHTLY HIGHER THAN INTENDED WITH PARTIAL COVERAGE OF THE OSTIUM OF A RENAL ARTERY. THE DEVICE WAS RECONSTRAINED AND THE PHYSICIAN ATTEMPTED TO REPOSITION BUT STRUGGLED WITH TRYING TO REPOSITION THE CXT AND CHOSE TO LEAVE IT AS IS AND IMPLANT A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) COVERED STENT IN ONE OF THE RENAL ARTERIES TO ENSURE GOOD FLOW. DURING POST-DILITATION OF THE VBX WITH A CODA BALLOON CATHETER THE RENAL ARTERY WAS RUPTURED DUE TO BELIEVED OVER-INFLATION OF THE BALLOON. THE PATENT EXPIRED INTRA-PROCEDURE, A CAUSE OF DEATH WAS NOT PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12334566 ↗
• MalfunctionJul 22, 2021Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT TO REPAIR AN ANEURYSM IN THE RIGHT INTERNAL ILIAC ARTERY UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX). THE PHYSICIAN WAS USING AN 8FR SHEATH AND WAS ABLE TO DELIVER THE VBX DEVICE TO THE INTENDED TREATMENT SITE. HOWEVER, PRIOR TO INITIATING DEPLOYMENT IT WAS OBSERVED THAT THE STENT HAD DETACHED FROM THE BALLOON. THE VBX DEVICE WAS THEN SUCCESSFULLY DEPLOYED AND IMPLANTED BY SEQUENTIAL BALLOONING USING 3MM, 8MM, AND 14MM BALLOONS. THE PHYSICIAN DID NOT HAVE ANY INPUT AS TO WHY THESE ISSUES OCCURRED. FURTHER INFORMATION WAS ASKED ABOUT PATIENT NAME, D.O.B, AND WEIGHT BUT WILL NOT BE MADE AVAILABLE. PATIENT TOLERATED THE PROCEDURE WITH NO ADVERSE OUTCOMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12210414 ↗
• MalfunctionMar 1, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2017, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS. A ZENITH FENESTRATED ENDOVASCULAR STENT GRAFT (ZFEN DEVICE) WAS IMPLANTED JUST DISTAL TO THE RENAL ARTERIES AND GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES (IBE DEVICES) WERE IMPLANTED TO EXTEND COVERAGE OF THE ZFEN DEVICE AND TREAT THE LEFT COMMON ILIAC ARTERY ANEURYSM (LCIAA). THE RIGHT COMMON ILIAC ARTERY ANEURYSM WAS NOT TREATED AT THIS TIME. ON (B)(6) 2019, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT, AND ADDITIONAL IBE DEVICES WERE IMPLANTED TO EXTEND COVERAGE OF THE ZFEN DEVICE AND TREAT THE RIGHT COMMON ILIAC ARTERY ANEURYSM (RCIAA). THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2021, THE PATIENT UNDERWENT REINTERVENTION FOR A SUSPECTED TYPE III ENDOLEAK AT THE JUNCTION OF THE IBE DEVICES AND EXTEND COVERAGE WITHIN THE LEFT HYPOGASTRIC ARTERY. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS ADVANCED VIA BRACHIAL ACCESS HOLD FOR ANIKA 3.8 THROUGH A 8FR X 45CM TERUMO SHEATH. THE PHYSICIAN EXPERIENCED DIFFICULTIES DUE TO TORTUOSITY AND THE LENGTH OF THE SHEATH AND THE DEVICE HAD WAS UNABLE TO ADVANCE OVER THE BEND

  Patient problems: Aneurysm

  MAUDE report 11396542 ↗

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