GORE VIABAHN VBX Balloon Expandable Endo BXAL087902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132637676), received between Jul 24, 2018 and May 16, 2024 — classified as 6 injuries, 5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024No Apparent Adverse Event; Migration; No Apparent Adverse Event; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, THE PATIENT WAS IMPLANTED WITH TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES TO TREAT A LEFT COMMON ILIAC ANEURYSM. ONE VBX DEVICE (26018390) WAS PLACED PROXIMAL LEFT COMMON ILIAC AND THE OTHER (26398872) WAS PLACED DISTAL LEFT COMMON ILIAC TO LEFT EXTERNAL ILIAC. REPORTEDLY, THE PHYSICIAN INTENTIONALLY COVERED THE LEFT HYPOGASTRIC ARTERY AS IT WAS ALREADY OCCLUDED. ON AN UNKNOWN DATE, THE PHYSICIAN NOTICED A TYPE IIIC ENDOLEAK BETWEEN THE TWO VBX DEVICES AS THERE WAS APPROXIMATELY 5MM OF GAP BETWEEN THE 2 VBX DEVICES. THE PHYSICIAN IMPLANTED A GORE® EXCLUDER® AAA ENDOPROSTHESIS TO RESOLVE THE ENDOLEAK AND TO RECONNECT THE GAP BETWEEN VBX DEVICES. THE PROCEDURE WAS CONCLUDED WITHOUT ANY OTHER REPORTED ISSUE AND PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 19337394 ↗
• InjuryApr 13, 2023Separation Problem; Separation Problem

  THE FOLLOWING INFORMATION WAS REPORT TO GORE: ON (B)(6) 2023, THE PATIENT UNDERWENT TREATMENT OF AN ILIAC ARTERY ANEURYSM USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. IT WAS REPORTED A FULLY CONSTRAINED VBX DEVICE STENT GRAFT SEPARATED FROM THE DELIVERY SYSTEM CATHETER IN THE PATIENT ILIAC ARTERY. THE PHYSICIAN STATED HIS SUSPECTED CAUSE OF THE SEPARATED STENT GRAFT IS UNKNOWN. THE STENT WAS NOT COVERING ANY VESSELS. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT GORE DEVICE. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2023, THE PATIENT UNDERWENT REINTERVENTION TO REMOVE THE CONSTRAINED VBX STENT GRAFT. A SNARE CATHETER WAS USED TO RETRIEVE THE STENT GRAFT. THE PATIENT TOLERATED THE PROCEDURE.

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

  MAUDE report 16738808 ↗
• MalfunctionApr 11, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE RIGHT COMMON ILIAC ARTERY FOR PERIPHERAL ARTERIAL DISEASE. IT WAS NOTED THAT THE VBX DEVICE DISLODGED DURING ATTEMPTED DEPLOYMENT WITH NO STENT EXPANSION. THE PHYSICIAN WAS ABLE TO RETRACT THE VBX DEVICE DELIVERY CATHETER WITHOUT DIFFICULTY. THEN, THE PHYSICIAN WAS ABLE TO USE A SMALL BALLOON (UNKNOWN MANUFACTURER/SIZE) TO EXPAND AND DEPLOY THE VBX DEVICE SUCCESSFULLY. THERE WERE NO ADVERSE CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombosis/Thrombus

  MAUDE report 16717994 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON APRIL 27, 2022, THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS(S) (VBX DEVICE) WERE PLACED IN THE RIGHT AND LEFT ILIAC VEINS FOR TREATMENT OF DEEP VEIN THROMBOSIS. ON (B)(6) 2022. AN ADDITIONAL VBX DEVICE WAS IMPLANTED IN THE ILIAC VEIN FOR TREATMENT OF AN UNKNOWN ETIOLOGY. ON AN UNKNOWN DATE THE PATIENT DEVELOPED AN INFECTION, POST OPERATION AND WAS PLACED ON VANCOMYCIN AND CEFEPIME TO TREAT THE INFECTION. ON (B)(6) 2022, THE PATIENT UNDERWENT AN ANGIOPLASTY AND THROMBECTOMY TO TREAT OCCLUDED DEVICES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 15941733 ↗
• MalfunctionSep 7, 2022Detachment of Device or Device Component; Separation Problem; Detachment of Device or Device Component; Separation Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE INTERNAL ILIAC FOR TREATMENT OF STENOSIS, DURING A AORTIC ANEURYSM REPAIR. THE PHYSICIAN PERFORMED AN ANGIOPLASTY WITH A SHOCKWAVE IVL ON THE CALCIFIED VESSEL PRIOR TO THE INTRODUCTION OF THE VBX DEVICE. HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE VBX DEVICE ACROSS THE CALCIFIED LESION, REMOVED THE VBX DEVICE AND PERFORMED AN ADDITIONAL ANGIOPLASTY WITH THE SHOCKWAVE IVL. THE PHYSICIAN ATTEMPTED TO ADVANCE THE VBX DEVICE (SAME DEVICE) ACROSS THE CALCIFIED LESION WITH NO SUCCESS AND REMOVED THE DEVICE AND AN ADDITIONAL ANGIOPLASTY WAS PERFORMED WITH THE SHOCKWAVE IVL. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE VBX DEVICE (SAME DEVICE) ACROSS THE CALCIFIED LESION WITH NO SUCCESS. WHEN REMOVING THE VBX DEVICE FROM THE CALCIFIED LESION, THE VBX DEVICE HAD BECOME DISLODGED FROM THE DELIVERY CATHETER. THE DECISION WAS MADE BY THE PHYSICIAN TO PIN THE VBX DEVICE AGAINST THE VESSEL WALL WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Aneurysm

  MAUDE report 15375381 ↗
• MalfunctionSep 20, 2021Material Separation

  PATIENT WAS HAVING SURGERY FOR ENDOVASCULAR THORACOABDOMINAL AORTIC ANEURYSM REPAIR WHEN THE STENT PRE-MATURELY SEPARATED FROM THE DELIVERY SYSTEM. SURGEON ABLE TO RETRIEVE UNDEPLOYED STENT COMPLETELY. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 12506868 ↗
• MalfunctionJul 22, 2021Malposition of Device; Premature Separation; Malposition of Device; 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) DEVICE. THE PHYSICIAN WAS USING AN 8FR SHEATH AND ATTEMPTING TO DELIVER THE VBX DEVICE TO THE TREATMENT ZONE. FOR UNKNOWN REASONS, THE DEVICE WAS UNABLE TO ACCURATELY BE PLACED, SO THE PHYSICIAN DECIDED TO REMOVE THE DEVICE. IT WAS THEN OBSERVED THAT THE UNDEPLOYED STENT HAD DETACHED FROM THE BALLOON, SO THE DEVICE WAS NOT REMOVED. INSTEAD, THE VBX DEVICE WAS 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 12210344 ↗
• InjuryJun 3, 2021Collapse; Collapse

  THE CLINICAL SPECIALIST REPORTED THE FOLLOWING INFORMATION: THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN INTERNAL ILIAC ARTERY ANEURYSM USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES AND TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) (21717425, UNK). IT WAS REPORTED THAT THE ILIAC BRANCH COMPONENT WAS SUCCESSFULLY PLACED WITH NO REPORTED ISSUES. WHEN THE PHYSICIAN ADVANCED THE INTERNAL ILIAC COMPONENT, IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO ADVANCE INTO THE PATIENT'S INTERNAL ILIAC ARTERY. THE UNDEPLOYED DEVICE WAS REMOVED, AND TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WERE USED IN THE PATIENT'S INTERNAL ILIAC ARTERY. AFTER PLACEMENT OF THE VBX DEVICES THE PHYSICIAN REPORTED GOOD BLOOD FLOW THROUGH THE INTERNAL ILIAC ARTERY. THE INTERNAL ILIAC COMPONENT WAS REPORTEDLY DISCARDED. AFTER PLACEMENT OF THE REMAINING DEVICES, A FINAL ANGIOGRAPHY WAS PERFORMED AND IT WAS REPORTED THAT THE PATIENT'S INTERNAL ILIAC ARTERY WAS OCCLUDED. THIS REPORT IS ASSOCIATED WITH VBX DEVICE LOT NUMBER 21717425.

  Patient problems: Obstruction/Occlusion

  MAUDE report 11934947 ↗
• InjuryDec 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN ANEURYSM BEGINNING IN THE RIGHT COMMON ILIAC ARTERY AND EXTENDING TO THE RIGHT INTERNAL ILIAC ARTERY AND UNDERWENT TREATMENT UTILIZING TWO GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE, CEB231010, HGB161007), A GORE® EXCLUDER® AAA ENDOPROSTHESIS (RLT231416) , AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE PHYSICIAN BEGAN BY ADVANCING AND DEPLOYING THE FIRST IBE (CEB231010) DEVICE SUCCESSFULLY AND A 12FR SHEATH WAS ADVANCED INTO THE IBE DEVICE. THE PHYSICIAN THEN CANNULATED THE RIGHT INTERNAL ILIAC ARTERY WITH A TERUMO GLIDEWIRE ADVANTAGE® GUIDEWIRE AND THEN EXCHANGED THE GUIDEWIRE FOR A 1CM TIP AMPLATZ WIRE THROUGH A KUMPE CATHETER. AN IBE (HGB161007) INTERNAL COMPONENT WAS THEN SUCCESSFULLY DEPLOYED IN THE IBE GATE. A VBX DEVICE WAS CHOSEN BASED ON A 7MM VESSEL DIAMETER, AND WAS DELIVERED SUCCESSFULLY AND DEPLOYED TO NOMINAL PRESSURE AT 12ATM. THE BALLOON WAS DEFLATED AND REMOVED AND A 10MMX20MM ARMADA BALLOON WAS DELIVERED TO THE OVERLAP OF THE IBE INTERNAL COMPONENT AND THE VBX DEVICE AND EXPANDED TO 6 ATM. THE PHYSICIAN THEN NOTICED A DROP IN PRESSURE AND A PERFORATION WA

  Patient problems: Embolism; Perforation

  MAUDE report 11007935 ↗
• MalfunctionOct 29, 2019Patient-Device Incompatibility; Detachment of Device or Device Component; Device Dislodged or Dislocated; Patient-Device Incompatibility; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A HYPOGASTRIC ARTERY, AN 8FR SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) OVER A GLIDE ADVANTAGE WIRE. OBTAINED INFORMATION STATE THE FACILITY DID NOT HAVE A LONG 8 FRENCH SHUTTLE SHEATH. THE PHYSICIAN ELECTED TO MOVE FORWARD WITH THE PROCEDURE USING A SHORT 8 FRENCH SHEATH. AS REPORTED, THE PATIENT HAS A VERY TORTUOUS ANATOMY. AN ILIAC BRANCH DEVICE WAS DEPLOYED VIA THE RIGHT GROIN. FROM THE BRACHIAL ARTERY ACCESS, THE VBX DELIVERY CATHETER WAS BEING ADVANCED WHEN IT BECAME STUCK MID THORACIC AORTA. DECISION WAS MADE TO WITHDRAW THE DELIVERY CATHETER OVER THE WIRE ONLY WITHOUT A LONG GUIDE SHEATH PRESENT. AFTER REMOVAL OF THE VBX DELIVERY CATHETER, IT WAS NOTICED THE STENT AND BALLOON WERE MISSING. THE STENT AND BALLOON WERE STILL ON THE WIRE IN THE MID THORACIC AORTA. FROM THE RIGHT GROIN ACCESS, A SNARE WAS USED TO REMOVE THE VBX STENT AND BALLOON. A NEW GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. THE AFFECTED DEVICE WAS DISCARDED AT USER FACILITY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9251337 ↗
• InjuryJul 24, 2018Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2018, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR AN INFRARENAL AORTIC ANEURYSM USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE ALSO IMPLANTED IN THE LEFT COMMON ILIAC ARTERY. ON (B)(6) 2018, ONE OF THE VBX DEVICE WAS FOUND TO BE OCCLUDED. A FEM-FEM BYPASS PROCEDURE WAS PERFORMED WAS PERFORMED AND PERFUSION WAS RESTORED. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 7717066 ↗

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