GORE VIABAHN VBX Balloon Expandable Endo BXAL085902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132637669), received between May 8, 2019 and Aug 23, 2024 — classified as 1 death, 1 injury, 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• DeathAug 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTIC ANEURYSM IN A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE A 22FR. GORE® DRYSEAL FLEX INTRODUCER SHEATH (DSF) THROUGH THE PATIENT'S PROXIMAL RIGHT EXTERNAL ILIAC ARTERY (EIA). CALCIFICATION WAS PRESENT IN THE ILIAC ARTERIES BILATERALLY. AN 8LX59 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED AND USED AS AN ENDO CONDUIT IN THE PATIENT'S PROXIMAL RIGHT EIA. THE 8LX59MM VBX DEVICE WAS POST DILATED WITH A 10/12MM PTA BALLOON AND THE 22FR. DSF SHEATH WAS RE-ADVANCED, BUT WAS STILL UNABLE TO ADVANCE PAST THE PROXIMAL EIA. USE OF A 20FR. COOK MEDICAL CHECK-FLO® INTRODUCER SHEATH WAS ALSO ATTEMPTED, BUT THE SHEATH WAS UNABLE TO ADVANCE. ACCESS WAS OBTAINED ON THE LEFT SIDE WITH A 22FR. DSF FOR DELIVERY OF THE TAMBE DEVICE SYSTEM. AT PROCEDURE COMPLETION, ANGIOGRAPHY WAS PERFORMED AND A RIGHT EIA RUPTURE AND EXTRAVASATION WAS OBSERVED JUST DISTAL TO THE VBX DEVICE ON THE PATIENT'S RIGHT SIDE. IT IS UNKNOWN IF THE VBX DEVICE OR INTRODUCER SHEATHS CAUSED OR CONTRIBUTED TO THE RIGHT EI

  Patient problems: Vascular Dissection

  MAUDE report 20057068 ↗
• MalfunctionApr 4, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT TREATMENT FOR A THORACIC ABDOMINAL ANEURYSM WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED TO BE IMPLANTED IN THE CELIAC ARTERY. IT WAS REPORTED THAT THE PHYSICIAN WAS USED A MEDTRONIC 12FR APTUS INTRODUCER SHEATH AND AN ABBOTT .035" TAD II GUIDEWIRE WHILE TRYING TO REACH THE TARGET TREATMENT AREA. WHILE ADVANCING THE VBX DEVICE THE PHYSICIAN ENCOUNTERED SOME RESISTANCE. IT WAS DECIDED TO WITHDRAW THE DEVICE THROUGH THE SHEATH IN ORDER TO EVALUATE THE SITUATION. AT THIS TIME, THE PHYSICIAN NOTICED THAT THE VBX DEVICE BECAME DISLODGED INSIDE OF THE SHEATH. THE SHEATH WAS WITHDRAWN FROM INSIDE OF THE PATIENT WHILE STILL HAVING THE VBX DEVICE INSIDE. DEPLOYMENT WAS NOT INITIATED AT ANY TIME OF THE PROCEDURE. THE PROCEDURE WAS COMPLETED USING A NEW SHEATH ALONG WITH A NEW VBX DEVICE. REPORTEDLY, THE PHYSICIAN STATED THAT THE VBX DEVICE DISLODGED OFF THE BALLOON DUE TO A KINK FOUND IN THE SHEATH. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047554 ↗
• MalfunctionFeb 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT PRESENTED FOR TREATMENT IN THE LEFT LEG DUE TO AN OBSERVED LEAK AFTER PLACEMENT OF A GORE® EXCLUDER® AAA ENDOPROSTHESIS. AS REPORTED, THE PATIENT'S ANATOMY WAS VERY TORTUOUS AND THE TARGET TREATMENT AREA WAS STENOTIC AND ANEURYSMAL. A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE DEVICE) WAS DEPLOYED IN THE INTERNAL ILIAC ARTERY. A 10MM X 65MM GORE® DRYSEAL FLEX INTRODUCER SHEATH (DRYSEAL SHEATH) WAS USED TO ADVANCE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). ALTHOUGH DIFFICULTY WAS EXPERIENCED DURING ADVANCEMENT THROUGH THE DRYSEAL SHEATH, ONE VBX DEVICE WAS PLACED AND DEPLOYED. NEXT, AN 8LMM X 59MM VBX DEVICE WAS TO BE ADVANCED. HOWEVER, THE IBE DEVICE AND THE FIRST DEPLOYED VBX DEVICE REPORTEDLY INTERFERED WITH ADVANCEMENT OF THE 8LMM X 59MM VBX DEVICE. AT THIS TIME, THE VBX STENT CAME OFF THE DELIVERY CATHETER. THE DISLODGED STENT AND SHEATH WERE REMOVED TOGETHER WITH NO ISSUES. COILING WAS PERFORMED INSTEAD OF ATTEMPTING TO PLACE ADDITIONAL DEVICES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. THE DEVICES NOT IMPLANTED WERE DISCARDED AT USER FACILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13509463 ↗
• MalfunctionDec 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO GORE THAT DURING A ILIAC LIMB EXTENSION PROCEDURE THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS CAME DISLODGED FROM THE INFLATION BALLOON. REPORTEDLY THE DEVICE WAS ALREADY AT THE INTENDED LOCATION AND THE PROCEDURE WAS COMPLETED USING THE SAME VBX DEVICE BY INSERTING INFLATION BALLOONS TO EXPAND THE DEVICE WITHIN THE PATIENT. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Stenosis

  MAUDE report 13101277 ↗
• MalfunctionSep 14, 2021Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT PRESENTED WITH AN ILIAC ARTERY ANEURYSM AND UNDERWENT TREATMENT WHICH INCLUDED USE OF A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE. THE SURGEON INTENDED TO USE THE VBX DEVICE IN CONJUNCTION WITH A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) DEVICE IN THE RIGHT INTERNAL/EXTERNAL ILIAC ARTERY GATE. WHILE ATTEMPTING TO POSITION THE DEVICE, THE VBX DEVICE DISLODGED FROM THE BALLOON INSIDE OF THE PATIENT. THE DEVICE COULD NOT BE MOVED, SO IT WAS LEFT UNDEPLOYED WHERE IT DISLODGED. IT WAS REPORTED THAT THE DEVICE MAY HAVE CAUGHT ON THE EDGE OF THE IBE DEVICE OR ON THE FRONT EDGE OF THE SHEATH WHILE PULLING BACK IN AN ATTEMPT TO PLACE THE DEVICE, CAUSING DISLODGEMENT. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER ISSUE BY COILING THE INTERNAL ILIAC ARTERY AND PLACING DEVICES OVER THE VBX DEVICE. THE PATIENT TOLERATED THE PROCEDURE. IT WAS ALSO REPORTED THAT THE 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH HAD NOT BEEN COMPLETELY EXTENDED INTO THE INTERNAL ILIAC ARTERY TO PROVIDE PROTECTION FOR THE VBX DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12468089 ↗
• InjuryFeb 11, 2020Complete Blockage; Complete Blockage

  ON (B)(6) 2020 THE PATIENT PRESENTED WITH COMPLETE OCCLUSION OF THE RIGHT COMMON ILIAC ARTERY.

  Patient problems: Vascular Dissection

  MAUDE report 9694896 ↗
• MalfunctionMay 8, 2019Premature Separation; Premature Separation

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR COMMON ILIAC ARTERY ANEURYSM REPAIR. THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) WAS BEING ADVANCED UP AND OVER THROUGH A AAA DEVICE (PREVIOUSLY IMPLANTED IN 2014) WITH THE HELP OF A DFS 12X45 SHEATH. THE DEVICE WAS ADVANCED TO THE 180° POINT AND THE DOCTOR FELT RESISTANCE. THE DOCTOR REPORTED THE VBX CATHETER SHAFT APPEARED TO ACCORDION. THE DOCTOR ELECTED TO REMOVE THE DEVICE AT THAT POINT. DURING REMOVAL THE STENT SEPARATED FROM THE BALLOON AND DELIVERY CATHETER, REMAINING IN THE SHEATH. THE SHEATH WAS REMOVED WITH THE STENT INSIDE. ANOTHER VBX WAS SUCCESSFULLY ADVANCED AND IMPLANTED.

  Patient problems: Aneurysm

  MAUDE report 8593494 ↗

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