GORE VIABAHN VBX Balloon Expandable Endo BXA061902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132637171), received between Sep 6, 2019 and Jul 2, 2025 — classified as 6 injuries, 2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE REVIEWED: COMPARISON OF BRIDGING STENT GRAFT TYPE IN FENESTRATED ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS. MAZROUA, M., ET AL. JOURNAL OF VASCULAR SURGERY VOLUME 81(4): E5. AVAILABLE ONLINE 17 MARCH 2025. THE ABSTRACT HIGHLIGHTED A RETROSPECTIVE REVIEW COMPARING TWO TYPES OF BALLOON-EXPANDABLE STENTS USED IN FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (FEVAR) PROCEDURES USING COMMERCIALLY AVAILABLE COOK ZENITH FENESTRATED GRAFTS AT A MULTIHOSPITAL HEALTH CARE INSTITUTION FROM 2014 TO 2022. REVIEW INCLUDED 139 PATIENTS (266 TARGET VESSELS), WITH 256/266 DEVICES IMPLANTED IN THE RENAL ARTERIES. ATRIUM ICAST WAS USED EXCLUSIVELY UNTIL 2017. AFTER 2017, A TOTAL OF 159 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED IN THE VISCERAL ARTERIES, AND ATRIUM ICAST USAGE DECREASED SIGNIFICANTLY. TECHNICAL SUCCESS WAS 96.2% (VBX 98.1%; ICAST 93.5%) DUE TO REQUIRED UNPLANNED EXTENSION RATES. AT ONE YEAR, FREEDOM FROM COMPLICATIONS WAS 117 FOR VBX DEVICES, AND 93 FOR ICAST. FIVE-YEAR RESULTS, ATRIUM ICAST DEMONSTRATED BETTER LONG-TERM FREEDOM FROM STENT-SPECIFIC COMPLICATIONS. PATIENT DETAILS OBTAINED FROM AUTHOR: ON (B)(6) 2021, ONE PATIENT WAS I

  Patient problems: Obstruction/Occlusion

  MAUDE report 22390995 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE REVIEWED: COMPARISON OF BRIDGING STENT GRAFT TYPE IN FENESTRATED ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS. MAZROUA, M., ET AL. JOURNAL OF VASCULAR SURGERY VOLUME 81(4): E5. AVAILABLE ONLINE 17 MARCH 2025. THE ABSTRACT HIGHLIGHTED A RETROSPECTIVE REVIEW COMPARING TWO TYPES OF BALLOON-EXPANDABLE STENTS USED IN FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (FEVAR) PROCEDURES USING COMMERCIALLY AVAILABLE COOK ZENITH FENESTRATED GRAFTS AT A MULTIHOSPITAL HEALTH CARE INSTITUTION FROM 2014 TO 2022. REVIEW INCLUDED 139 PATIENTS (266 TARGET VESSELS), WITH 256/266 DEVICES IMPLANTED IN THE RENAL ARTERIES. ATRIUM ICAST WAS USED EXCLUSIVELY UNTIL 2017. AFTER 2017, A TOTAL OF 159 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED IN THE VISCERAL ARTERIES, AND ATRIUM ICAST USAGE DECREASED SIGNIFICANTLY. TECHNICAL SUCCESS WAS 96.2% (VBX 98.1%; ICAST 93.5%) DUE TO REQUIRED UNPLANNED EXTENSION RATES. AT ONE YEAR, FREEDOM FROM COMPLICATIONS WAS 117 FOR VBX DEVICES, AND 93 FOR ICAST. FIVE-YEAR RESULTS, ATRIUM ICAST DEMONSTRATED BETTER LONG-TERM FREEDOM FROM STENT-SPECIFIC COMPLICATIONS. AUTHOR PROVIDED THE FOLLOWING: ON (B)(6) 2022, ONE PATIENT HAD AN IMPLA

  Patient problems: Obstruction/Occlusion

  MAUDE report 22388656 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITERATURE REVIEWED: COMPARISON OF BRIDGING STENT GRAFT TYPE IN FENESTRATED ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSMS. MAZROUA, M., ET AL. JOURNAL OF VASCULAR SURGERY VOLUME 81(4): E5. AVAILABLE ONLINE 17 MARCH 2025. THE ABSTRACT HIGHLIGHTED A RETROSPECTIVE REVIEW COMPARING TWO TYPES OF BALLOON-EXPANDABLE STENTS USED IN FENESTRATED ENDOVASCULAR ANEURYSM REPAIR (FEVAR) PROCEDURES USING COMMERCIALLY AVAILABLE COOK ZENITH FENESTRATED GRAFTS AT A MULTIHOSPITAL HEALTH CARE INSTITUTION FROM 2014 TO 2022. REVIEW INCLUDED 139 PATIENTS (266 TARGET VESSELS), WITH (B)(4) DEVICES IMPLANTED IN THE RENAL ARTERIES. ATRIUM ICAST WAS USED EXCLUSIVELY UNTIL 2017. AFTER 2017, A TOTAL OF (B)(4) GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED IN THE VISCERAL ARTERIES, AND ATRIUM ICAST USAGE DECREASED SIGNIFICANTLY. TECHNICAL SUCCESS WAS 96.2% (VBX 98.1%; ICAST 93.5%) DUE TO REQUIRED UNPLANNED EXTENSION RATES. AT ONE YEAR, FREEDOM FROM COMPLICATIONS WAS 117 FOR VBX DEVICES, AND 93 FOR ICAST. FIVE-YEAR RESULTS, ATRIUM ICAST DEMONSTRATED BETTER LONG-TERM FREEDOM FROM STENT-SPECIFIC COMPLICATIONS. FOR ONE PATIENT WITH AN IMPLANT OF VBX DEVICE IN THE LEFT RENAL ARTER

  Patient problems: Obstruction/Occlusion

  MAUDE report 22387953 ↗
• MalfunctionApr 26, 2022Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT PRESENTED FOR TREATMENT OF AN ANEURYSM THAT INCLUDED THE USE OF A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE. THE PHYSICIAN WAS PERFORMING A MODIFIED FENESTRATED CASE AS A REINTERVENTION FOR TWO PREVIOUSLY IMPLANTED SUPRARENAL BARE METAL STENTS. THE PROCEDURE UTILIZED LASER FENESTRATION TO ACCESS THE CELIAC ARTERY AND A 12FR TERUMO NAGARE STEERABLE SHEATH WAS USED TO ADVANCE THE VBX DEVICE TO THE CELIAC ARTERY. UPON WITHDRAWING THE SHEATH, IT WAS NOTICED THAT THE UNDEPLOYED VBX DEVICE HAD BECOME DISLODGED FROM THE DELIVERY CATHETER INSIDE OF THE SHEATH DUE TO THE CURVATURE OF THE TERUMO NAGARE STEERABLE SHEATH. THE DISLODGED STENT REMAINED WITHIN THE SHEATH AND WAS REMOVED FROM THE PATIENT WHEN THE SHEATH WAS REMOVED. THE PATIENT TOLERATED THE PROCEDURE WITH NO REPORTED ADVERSE IMPACTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14205465 ↗
• InjurySep 3, 2020Migration; Migration

  ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN UNKNOWN ETIOLOGY IN THE RENAL ARTERY AND UNDERWENT TREATMENT USING A GORE® VIABAHN® ENDOPROSTHESIS (VSX) AND THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE PHYSICIAN DEPLOYED THE FIRST VBX DEVICE APPROXIMATELY <1 CM SHALLOW IN THE TREATMENT ZONE. THEN THE PHYSICIAN EXTENDED THE PLACED ENDOPROSTHESIS WITH AN ADDITIONAL VBX DEVICE. THE PHYSICIAN THEN DEPLOYED A VSX DEVICE TO LINE BOTH VBX DEVICES. WHILE ATTEMPTING TO REMOVE THE ROSEN GUIDEWIRE, THE WIRE DISLODGED ALL OF THE STENTS AND PULLED THE VBX & VSX DEVICES OUT OF THE VESSEL. THE PHYSICIAN WAS THEN ABLE TO SNARE ALL THREE DEVICES AND CAPTURE THE DEVICES FOR REMOVAL WITH A LARGE BORE SHEATH. A FEMORAL CUT DOWN WAS THEN USED TO REMOVE ALL SNARED DEVICES FROM PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10491595 ↗
• InjurySep 3, 2020Migration; Migration

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN UNKNOWN ETIOLOGY IN THE RENAL ARTERY AND UNDERWENT TREATMENT USING A GORE® VIABAHN® ENDOPROSTHESIS (VSX) AND THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE PHYSICIAN DEPLOYED THE FIRST VBX DEVICE APPROXIMATELY <1 CM SHALLOW IN THE TREATMENT ZONE. THEN THE PHYSICIAN EXTENDED THE PLACED ENDOPROSTHESIS WITH AN ADDITIONAL VBX DEVICE. THE PHYSICIAN THEN DEPLOYED A VSX DEVICE TO LINE BOTH VBX DEVICES. WHILE ATTEMPTING TO REMOVE THE ROSEN GUIDEWIRE, THE WIRE DISLODGED ALL OF THE STENTS AND PULLED THE VBX & VSX DEVICES OUT OF THE VESSEL. THE PHYSICIAN WAS THEN ABLE TO SNARE ALL THREE DEVICES AND CAPTURE THE DEVICES FOR REMOVAL WITH A LARGE BORE SHEATH. A FEMORAL CUT DOWN WAS THEN USED TO REMOVE ALL SNARED DEVICES FROM PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10491522 ↗
• InjuryNov 20, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2019 THE PATIENT PRESENTED WITH STENOTIC OCCLUSION IN THE MESENTERIC ARTERY. AN 8MM X 19MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS TO BE DEPLOYED. HOWEVER, WHEN THE PHYSICIAN WAS TRYING TO CROSS THE LESION, THE DEVICE GOT STUCK IN THE AREA OF STENOSIS. THE AREA OF STENOSIS WAS NOT PRE-BALLOONED PRIOR TO THE ADVANCEMENT OF THE DEVICE. WHEN THE PHYSICIAN WAS TRYING TO ADJUST THE DEVICE, IT DISLODGED FROM THE BALLOON. THE PHYSICIAN REMOVED THE CATHETER AND HAD TO PERFORM AN OPEN PROCEDURE TO RETRIEVE THE DEVICE. THE PHYSICIAN SUSPECTED THAT THE DEVICE MAY HAVE BECOME STUCK IN SOME CALCIFICATION. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient; Occlusion; Stenosis

  MAUDE report 9349765 ↗
• MalfunctionSep 6, 2019Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Premature Separation; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Premature Separation

  THE PATIENT PRESENTED FOR A AAA FENESTRATED CASE. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS TARGETED TO GO INTO THE RENAL. THE DOCTOR WAS UNABLE TO PLACE THE SHEATH INTO THE RENAL SO DECIDED TO ADVANCE THE VBX BAREBACK. DURING ADVANCEMENT, THE STENT DISLODGED FROM THE BALLOON. THE BALLOON AND STENT WERE RETRIEVED AND DISCARDED AT THE HOSPITAL.

  Patient problems: Aneurysm

  MAUDE report 8972944 ↗

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