GORE VIABAHN VBX Balloon Expandable Endo BXAL085901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132637836), received between Sep 6, 2018 and Feb 21, 2024 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 21, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT PRESENTED FOR ANEURYSM PROCEDURE AND TREATMENT IN THE LEFT COMMON ILIAC ARTERY. AS REPORTED, A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT (IBE DEVICE) WAS UTILIZED, IN ADDITION TO A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) AND A GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS (CEXC DEVICE). THE PHYSICIAN WAS ABLE TO IMPLANT THE IBE DEVICE IN THE ILIAC BIFURCATION SUCCESSFULLY. THE VBX DEVICE WAS THEN ADVANCED USING A 10FRX65CM DRY SEAL SHEATH AND WAS ADVANCED OVER A AMPLATZ WIRE INTO THE LEFT INTERNAL ILIAC AND PLACED JUST PROXIMAL TO THE A/P DIVISION. THE 10FR SHEATH WAS RETRACTED JUST DISTAL TO THE STENT BUT AROUND THE FLOW DIVIDER. HOWEVER, WHEN THE SHEATH WAS RETRACTED, IT ALSO PULLED THE STENT BACK AND AWAY FROM THE TARGET LANDING ZONE. IT WAS THEN ATTEMPTED TO RE-ADVANCE THE STENT BUT IT HAD LOST THE PUSHABILITY WITH THE SHEATH PULLED BACK AND WOULD NOT RE-ADVANCE. THE STENT WAS RETRACTED BACK INTO THE SHEATH TO REMOVE IT COMPLETELY AND RE-ADVANCE THE SHEATH. WHEN IT WAS PULLED BACK THE STENT WAS DISLODGED FROM THE BALLOON AND STUCK IN THE ANTERIOR BRANCH OF THE LEFT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18753841 ↗
• InjuryOct 20, 2021Compatibility Problem; Compatibility Problem

  ON (B)(6) 2021 THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM AND LEFT ILIAC ARTERY ANEURYSM USING GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESES AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX). A GORE® EXCLUDER® ILIAC BRANCH COMPONENT WAS PLACED IN THE PATIENT'S LEFT COMMON ILIAC ARTERY, AND A VBX DEVICE WAS PLACED IN THE PATIENT'S LEFT INTERNAL ILIAC ARTERY. IT WAS NOTED THAT THE CASE WAS OFF OF IFU DUE TO THE PATIENT'S PROXIMAL COMMON ILIAC ARTERY ORIGIN BEING SMALL. ON (B)(6) 2021 THE PATIENT PRESENTED FOR POST-OP FOLLOW-UP. THE PATIENT REPORTED HAVING LEFT LEG COLDNESS, NUMBNESS, AND THIGH AND HIP CLAUDICATION WHILE STANDING OR WALKING SINCE (B)(6) 2021. THE PATIENT HAD BEEN UNABLE TO PALPATE A PULSE IN THE LEFT FOOT. NORMAL MOTOR AND SENSORY FUNCTION OF THE PATIENT'S LEFT FOOT WAS REPORTED BY THE PHYSICIAN, AND THE PHYSICIAN CONFIRMED THAT NO LEFT FEMORAL, POPLITEAL, OR PEDAL PULSES WERE ABLE TO BE PALPATED. A DUPLEX SCAN WAS PERFORMED AND A CLOT WAS OBSERVED IN THE PATIENT'S COMMON ILIAC ARTERY. THE CAUSE OF THE CLOT WAS REPORTEDLY DUE TO THE SMALL SIZE OF THE PATIENT'S COMMON ILIAC ARTERY ORIGIN. THE ILIAC BRANCH COMPONENT WAS OCCLU

  Patient problems: Cramp(s) /Muscle Spasm(s); Pain; Thrombosis/Thrombus

  MAUDE report 12666161 ↗
• MalfunctionOct 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A PATIENT PRESENTED WITH AN ILIAC ARTERY OCCLUSION. AS REPORTED, THE ARTERY WAS TORTUOUS AND HEAVILY CALCIFIED. FROM THE COMMON FEMORAL ACCESS, AN 8FR CORDIS BRITE TIP® SHEATH WAS PLACED AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS ADVANCED TO THE INTENDED TREATMENT SITE. BEFORE ATTEMPTING TO DEPLOY THE VBX DEVICE, THE PHYSICIAN DECIDED TO DO ANOTHER ANGIOGRAM AS THE VBX DEVICE APPEARED TOO SHORT. THE VBX DEVICE WAS ATTEMPTED TO BE PULLED BACK THROUGH THE SHEATH AFTER IT WAS FULLY INTRODUCED INTO VESSEL. REPORTEDLY, PRESSURE WAS EXPERIENCED AS THE DEVICE WAS PULLED. THE VBX STENT WAS CAUGHT ON CALCIFICATION. DISLODGING IT FROM THE BALLOON CATHETER. A NEW VBX DEVICE WAS USED TO PIN THE CONSTRAINED VBX STENT AGAINST THE ILIAC VESSEL WALL. GOOD BLOOD FLOW WAS RE-ESTABLISHED TO THE PATIENT'S FOOT. THE PATIENT WAS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12625498 ↗
• MalfunctionJan 4, 2021Retraction Problem; Detachment of Device or Device Component; Retraction Problem; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT PRESENTED WITH AN ANEURYSM IN THE LEFT ILIAC ARTERY AND UNDERWENT TREATMENT UTILIZING THREE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBE) AND TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX). THE INITIAL IBE DEVICE WAS SUCCESSFULLY DEPLOYED INTO THE LT COMMON ILIAC. A 16FR DRY SEAL SHEATH WAS THEN DRIVEN UP AND OVER THE AORTIC BIFURCATION ON A 180CM STIFF GLIDEWIRE ADVANTAGE® GUIDEWIRE AND POSITIONED IN THE IBE GATE. A 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS THEN INSERTED INTO THE 16FR SHEATH AND ADVANCED UNTIL THE END OF THE 12FR SHEATH WAS OUT OF THE 16FR SHEATH. THE PHYSICIAN THEN ADVANCED A 180CM BENTSON WIRE THROUGH THE 12FR SHEATH AND CANNULATED THE LT INTERNAL ARTERY WITHOUT DIFFICULTY AND BURIED DEEP INTO THE POSTERIOR BRANCH AND CONFIRMED. THE BENTSON WIRE WAS THEN SWAPPED OUT, UTILIZING A COOK BEACON® TIP 5.0 FR ANGIOGRAPHIC CATHETER, FOR A ROSEN WIRE AND A MEASUREMENT WAS TAKEN TO DETERMINE VBX LENGTH OF 59MM. THE VBX WAS PREPPED AND SUCCESSFULLY LOADED ON TO THE ROSEN WIRE AND BEGAN ADVANCING THROUGH THE 12FR SHEATH TO THE TARGET LOCATION IN THE PROXIMAL PORTION OF THE POSTERIOR BRAN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11113511 ↗
• MalfunctionMay 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF UNKNOWN TYPE/LOCATION WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. REPORTEDLY THE DEVICE BROKE AFTER IT WAS DEPLOYED. THE DELIVERY SYSTEM WAS ATTEMPTED TO BE PULLED OUT OF THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8618142 ↗
• MalfunctionSep 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS BEING UTILIZED IN ONE OF THE ILIAC ARTERIES. THE DEVICE WAS LOADED ONTO A .035" WIRE AND PASSED THROUGH AN 8FR. SHEATH, HOWEVER THIS MANEUVER REQUIRED HIGH FORCE. THE DEVICE WAS DEPLOYED IN THE DESIRED LOCATION, BUT WHEN THE DELIVERY SYSTEM WAS BEING REMOVED, THE DELIVERY CATHETER BECAME SEPARATED FROM THE HUB, WHILE IN THE SHEATH, INSIDE THE BODY. ALL OF THE DELIVERY SYSTEM COMPONENTS WERE SUCCESSFULLY REMOVED FROM THE PATIENT, WITH NO INJURY. THE PATIENT DID WELL FOLLOWING THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7852182 ↗

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