GORE VIABAHN VBX Balloon Expandable Endo BXA085902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00733132637331), received between Mar 25, 2019 and Feb 18, 2025 — classified as 1 death, 5 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2025Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE TO TREAT AN UNKNOWN ETIOLOGY WHERE AN 8 MM X 59 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED TO BE USED IN AN UNKNOWN ANATOMICAL LOCATION. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT USING A 7F COOK FLEXOR INTRODUCER SHEATH (45 CM) OVER AN UNKNOWN SIZE / BRAND GUIDE WIRE. REPORTEDLY, DURING ADVANCEMENT OF THE DELIVERY CATHETER, A LOT OF RESISTANCE WAS ENCOUNTERED IN THE SHEATH. THE DECISION WAS MADE TO WITHDRAW THE DELIVERY CATHETER. DURING WITHDRAWAL ADDITIONAL RESISTANCE WAS FELT. THE DELIVERY CATHETER WOULD NOT COME OUT OF THE SHEATH. THE SHEATH WAS REMOVED WITH THE DELIVERY CATHETER STUCK INSIDE. REPORTEDLY, THE ATTEMPT TO MAINTAIN GROIN ACCESS DURING REMOVAL OF THE SHEATH / DELIVERY CATHETER, MADE THE INCISION SITE BIGGER. THE PATIENT WAS MOVED FROM THE INTERVENTIONAL RADIOLOGY SUITE TO THE OPERATING ROOM FOR CLOSURE. IT WAS REPORTED THE PATIENT IS DOING FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21398827 ↗
• MalfunctionNov 25, 2024Material Integrity Problem; Material Integrity Problem

  A STUDY ALERT FROM THE PIVOTAL AAA 17-01 (TAMBE) CLINICAL STUDY WAS RECEIVED: ON (B)(6) 2021, THE PATIENT UNDERWENT A THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) ENDOVASCULAR PROCEDURE TO TREAT AN AORTIC ANEURYSM USING A 8 MM X 59 MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED IN THE CELIAC ARTERY SIDE BRANCH. ON (B)(6) 2021, DURING A 1 MONTH FOLLOW-UP, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) IMAGING WAS PERFORMED. OVALIZATION OF THE VBX DEVICE IN THE DISTAL END OF THE CELIAC ARTERY WAS OBSERVED. DURING FOLLOW-UP CTA IMAGING AT 6, 12, 24, AND 36 MONTHS OVALIAZTION OF THE VBX DEVICE WAS ALSO OBSERVED. DURING ALL THE FOLLOW-UP APPOINTMENTS, ALL BRANCH DEVICES WERE NOTED AS PATENT AND THERE WERE NO VBX DEVICE WIRE FRACTURES REPORTED. THE STUDY PATIENT IS ASYMPTOMATIC AND NO INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20773014 ↗
• DeathMay 4, 2023Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE FROM A STUDY: ON (B)(6) 2020, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM IN THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) CLINICAL TRIAL. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICE) WERE IMPLANTED AS SIDE BRANCHES IN THE PATIENT'S SUPERIOR MESENTERIC ARTERY (SMA), CELIAC ARTERY, PLUS THE RENAL ARTERIES (LEFT AND RIGHT). ON (B)(6) 2023, PATIENT PRESENTED WITH ACUTE MESENTERIC ISCHEMIA AND BILATERAL RENAL ARTERY OCCLUSION. AS REPORTED, TREATMENT WAS REQUIRED. THE TYPE OF TREATMENT RENDERED WAS NOT SPECIFIED.

  Patient problems: Renal Failure; Thrombosis/Thrombus

  MAUDE report 16872162 ↗
• InjuryJan 20, 2023Partial Blockage; Partial Blockage

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT PRESENTED LEFT ILIAC ARTERY STENOSIS, WITH A MILD INFRARENAL ABDOMINAL AORTA ANEURYSM (AAA) WHICH WAS BELIEVED TO HAVE THROMBOSED, CAUSING EMBOLI AND CAUSING THE STENOSIS. ON (B)(6) 2022, THE PATIENT UNDERWENT AORTOILIAC GRAFTING WITH MULTIPLE GORE AORTIC DEVICES. THE PATIENT WAS NOTED TO HAVE CHRONIC MICRO-EMBOLI DISTALLY AND COMPLETE REVASCULARIZATION WAS NOT ACHIEVED. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS IMPLANTED IN THE LEFT COMMON ILIAC ARTERY (CIA). A 10MM X 7CM ILIAC EXTENDER ENDOPROSTHESIS WAS ALSO IMPLANTED ABOVE THE LEFT CIA. THE PATIENT WAS STARTED ON ELIQUIS AND TREATED WITH ANTIBIOTICS FOR POSSIBLE PNEUMONIA. PATIENT WAS DISCHARGED IN A STABLE CONDITION ON (B)(6) 2022. ON (B)(6) 2022, PATIENT PRESENTED WITH WORSENING FOOT LEFT FOOT PAIN AND SWELLING, WITH PAIN RADIATING FROM FOOT TO CALF. REPORTEDLY, THIS DECREASED WITH REST AND PAIN MEDICATION. ULTRASOUND IN LEFT LOWER EXTREMITY REVEALED RIGHT PERONEAL AND POSTERIOR TIBIAL DVT. CTA AORTA WITH RUNOFF SHOWED A LEFT PROXIMAL TIBIAL ARTERY OCCLUSION. HEPARIN INFUSION WAS ADMINISTERED OVERNIGHT. PATIENT WAS ALSO STARTED ON EMPIRIC ANTIBIOTI

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 16217281 ↗
• MalfunctionSep 12, 2022Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022 A PATIENT PRESENTED WITH PERIPHERAL ARTERIAL DISEASE AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE IN THE COMMON ILIAC ARTERY. THE VBX DEVICE WAS PLACED OVER AN 0.035" GUIDEWIRE (BRAND UNKNOWN) AND ADVANCED THROUGH A 7FR CORDIS BRITE TIP® SHEATH. THE VBX DEVICE WAS HAVING DIFFICULTY BEING ADVANCED THROUGH THE SHEATH SO THE PHYSICIAN DECIDED TO REMOVE THE VBX DEVICE FROM THE PATIENT. DURING REMOVAL, THE VBX DEVICE DISLODGED FROM THE DELIVERY CATHETER. THE VBX DEVICE REMAINED ON THE GUIDEWIRE AND THE PHYSICIAN WAS ABLE TO RETRIEVE IT THROUGH THE SHEATH ACCESS SITE WITHOUT THE SHEATH IN PLACE. THE PROCEDURE WAS THEN COMPLETED UTILIZING TWO ALTERNATE VBX DEVICES AND AN 8 FR TERUMO PINNACLE® SHEATH WITHOUT FURTHER ISSUE. THERE WAS NO REPORTED HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15405442 ↗
• MalfunctionAug 9, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2022, THE PATIENT WAS BEING TREATED FOR A STENOTIC OCCLUSION IN THE COMMON FEMORAL ARTERY USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE DEVICE WAS REPORTED TO HAVE MET RESISTANCE ADVANCING THROUGH A 7FR SHEATH (BRAND UNKNOWN). HOWEVER, THE DEVICE WAS ABLE TO BE ADVANCED TO ITS INTENDED LOCATION. IT WAS IDENTIFIED PRIOR TO ATTEMPTING TO DEPLOY THE DEVICE THE STENT GRAFT HAD BECOME SEPARATED FROM THE DELIVERY CATHETER. THE DEVICE WAS ABLE TO BE EXPANDED AND DEPLOYED WITH A SURGICAL BALLOON 7 X 60. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15195591 ↗
• MalfunctionMar 25, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO GORE THAT DURING A PROCEDURE FOR TREATMENT OF THE EXTERNAL ILIAC AND COMMON ILIAC, THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS CAME DETACHED FROM THE BALLOON WHILE INSIDE THE PATIENT. REPORTEDLY THE PHYSICIAN WAS UNABLE TO CROSS THE LESION OF THE COMMON ILIAC AND ATTEMPTED TO DRAW THE DEVICE BACK INTO THE SHEATH, AT WHICH POINT THE DEVICE CAME DETACHED FROM THE BALLOON. IT WAS REPORTED THAT THE DEVICE WAS ABLE TO BE IMPLANTED AT THE SECOND TARGET SITE IN THE EXTERNAL ILIAC. REPORTEDLY THE PROCEDURE TO TREAT THE COMMON ILIAC WAS COMPLETED USING ANOTHER GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. IT WAS REPORTED THAT THERE WAS NO ADVERSE PATIENT OUTCOME AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13906124 ↗
• InjuryOct 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE WAS INTENDED FOR USE IN THE RIGHT COMMON ILIAC ARTERY. THE PHYSICIAN GOT LEFT COMMON FEMORAL ARTERY (LCF) ACCESS ATTEMPTING STENT PLACEMENT IN THE RIGHT (RT) COMMON ILIAC, UP AND OVER THE AORTIC BIFURCATION THROUGH A 7FR X 45CM TERUMO SHEATH OVER A 0.035" ROSEN WIRE. THE PATIENT HAD SEVERELY CALCIFIED VESSELS SO THE INTRODUCER SHEATH CAME BACK AS HE WAS TRYING TO PUSH STENT OVER THE AORTIC BIFURCATION. WHEN HE TRIED TO ADJUST THE INTRODUCER SHEATH, THE VBX DEVICE CAUGHT ON THE SHEATH TIP AND DISLODGED FROM THE BALLOON. THE VBX DEVICE STAYED ON WIRE AND HE WAS ABLE TO PULL THE STENT DOWN TO THE LEFT COMMON FEMORAL (LCF) WHERE HE ELECTED TO DO AN OPEN CUTDOWN ON THE LCF AND SUCCESSFULLY RETRIEVED THE VBX DEVICE. STENTING THE RT COMMON ILIAC WAS ABORTED AND SCHEDULED FOR THE FOLLOWING DAY. THE FOLLOWING DAY, A VBX DEVICE WAS SUCCESSFULLY DELIVERED WITH NO INCIDENT.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 12591764 ↗
• MalfunctionAug 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT USING A KISSING TECHNIQUE IN THE COMMON ILIAC ARTERIES, THE LEFT SIDE HAD TIGHT STENOSIS AND THE RIGHT SIDE HAD A PREVIOUSLY IMPLANTED STENT (UNKNOWN MANUFACTURER). A 7FR CORDIS BRITE TIP CATHETER INTRODUCER WAS USED TO ADVANCED THE GORE¿ VIABAHN¿ VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) OVER A .035 STIFF WIRE GUIDEWIRE. AS REPORTED, THE VBX DEVICE DID NOT REACH THE COMMON ILIAC ARTERY AND AS IT WAS BEING PULLED BACK THROUGH THE SHEATH, THE VBX DEVICE CAME OFF THE BALLOON. THE VBX DEVICE WAS DEPLOYED IN THE EXTERNAL ILIAC ARTERY. A NEW VBX DEVICE WAS INSERTED AND WAS ABLE TO REACH THE COMMON ILIAC ARTERY AND DEPLOYED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12387561 ↗
• MalfunctionAug 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS INTENDED FOR USE IN THE ILIAC ARTERY TO TREAT SEVERE OCCLUSION. THE PHYSICIAN MADE A FEW ATTEMPTS TO CROSS THE LESION BUT COULD NOT CROSS THE SEVERE OCCLUSION. THE DECISION WAS MADE TO REMOVE THE DEVICE AND PERFORM AN ANGIOPLASTY. DURING THE REMOVAL OF THE DEVICE IT HAD BECOME DISLODGED. THE PHYSICIAN ATTEMPTED TO REMOVE THE DEVICE WITH A SNARE, BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN ADVANCED A BALLOON THROUGH THE DEVICE AND DEPLOYED THE VBX DEVICE IN THE VESSEL.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12302325 ↗
• MalfunctionOct 19, 2020Migration; Migration

  AFTER AN AORTIC CASE WAS COMPLETED, THE PHYSICIAN TREATED AN ILIAC ARTERY ANEURYSM THAT WAS NEAR THE BIFURCATION. AN 8 X 39 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS DEPLOYED AND POST DILATED WITH A 10MM BALLOON. TO EXTEND THE FIRST DEVICE PROXIMALLY, AN 8 X 59MM VBX DEVICE WAS ADVANCED AND DEPLOYED. HOWEVER, IT WAS FOUND THIS DEVICE DID NOT HAVE ENOUGH WALL APPOSITION AFTER THE BALLOONING WAS COMPLETED. WHEN THE BALLOON CATHETER WAS WITHDRAWN, THE DEPLOYED VBX DEVICE MIGRATED TO THE DISTAL END OF THE FIRST DEVICE. THE 8X59 VBX DEVICE LANDED WITH GOOD WALL APPOSITION IN THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN ELECTED NOT TO PLACE ANY OTHER DEVICES AS THE HYPOGASTRIC ARTERY MAINTAINED GOOD BLOOD FLOW. AS REPORTED, THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10702329 ↗
• MalfunctionOct 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR TREATMENT OF A SPLENIC ARTERY ANEURYSM. USING A 7FR PINNACLE® DESTINATION® GUIDING SHEATH, THE 8X59 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS ATTEMPTED TO BE ADVANCED THROUGH VERY TORTUOUS ANATOMY. THE VBX DEVICE WAS UNABLE TO REACH THE INTENDED TREATMENT SITE. THE PHYSICIAN ELECTED TO PULL THE VBX DEVICE BACK INTO THE SHEATH. AS THE VBX DEVICE WAS PULLED INTO THE SHEATH THE PROXIMAL END OF THE VBX DEVICE SNAGGED ON THE SHEATH, CAUSING THE STENT TO DISLODGE FROM THE DELIVERY CATHETER. AN .014 WIRE WAS INSERTED THROUGH THE DISLODGED STENT, AND THE STENT WAS PULLED IT INTO THE COMMON ILIAC ARTERY. THE VBX DEVICE WAS EXPANDED USING THREE CARDIAC BALLOONS. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. THE PROCEDURE WAS ABORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10678789 ↗
• InjuryApr 9, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020 A PATIENT UNDERWENT A BILATERAL COMMON ILIAC STENTING, IN THE COMMON ILIAC ARTERY. USING AN 8 FR 10 CM TERUMO SHEATH, THE PHYSICIAN ADVANCED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) THROUGH THE COMMON FEMORAL ARTERY. IT WAS REPORTED THE ARTERY HAD CALCIUM PRESENT AND THE PHYSICIAN BELIEVES IT CAUSED THE DEVICE TO SLIP OFF THE BALLOON IN THE FEMORAL ARTERY. A VASCULAR SURGEON ASSISTED IN THE PROCEDURE AND PERFORMED A CUT DOWN OF THE COMMON FEMORAL ARTERY TO REMOVE THE UN-DEPLOYED VBX DEVICE. THEY PROCEEDED TO USE A NEW VBX DEVICE OF THE SAME SIZE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING FINE.

  Patient problems: No Code Available

  MAUDE report 9946461 ↗
• InjuryApr 1, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, THE PATIENT WAS BEING TREATED FOR STENOSIS IN THE COMMON ILIAC ARTERY USING GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. IT WAS REPORTED THE DEVICE MET RESISTANCE AS IT WAS BEING ADVANCED THROUGH THE SHEATH. THE DEVICE WAS REMOVED FROM THE PATIENT. A SECOND ATTEMPT TO ADVANCED THE SAME DEVICE THROUGH THE SHEATH WAS SUCCESSFUL. IT WAS REPORTED AS THE DEVICE WAS BEING ADVANCED TO ITS INTENDED LOCATION RESISTANCE WAS MET AND THE STENT WAS DISLODGED FROM THE CATHETER. THE PHYSICIAN STATED IT IS UNKNOWN WHAT CAUSED THE STENT TO BECOME DISLODGED FROM THE CATHETER. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. A CUT DOWN PROCEDURE WAS PERFORMED TO REMOVE THE DEVICE FROM THE PATIENT'S COMMON ILIAC ARTERY. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 9914281 ↗
• MalfunctionMar 25, 2019Premature Separation; Premature Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF A STENOTIC OCCLUSION OF THE LEFT COMMON ILIAC ARTERY WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE DEVICE WAS ADVANCED OVER A .035" WIRE THROUGH A 7FR SHEATH. WHILE TRACKING THOUGH THE ILIAC ARTERY THE STENT CAME OFF THE BALLOON CATHETER. IT WAS IN AN ACCEPTABLE LOCATION, SO THE STENT WAS BALLOONED WHERE IT LANDED. THERE WERE NO ADVERSE OUTCOMES FOR THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8450278 ↗

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