GORE VIABAHN VBX Balloon Expandable Endo BXB062902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132658428), received between May 17, 2024 and Oct 16, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jul 1, 2024Class IIOpen, Classified

   Due to packaging defects, sterility assurance and heparin activity may be compromised.

   Z-2945-2024 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE INVOLVING A LASER-CREATED FENESTRATION FOR AAA AORTIC REPAIR. THE MAIN AORTIC COMPONENT USED WAS A MEDTRONIC AAA DEVICE. DURING THE PROCEDURE, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (GORE® VBX DEVICES) WAS SELECTED. REPORTEDLY, THE ENDOPROSTHESIS DISLODGED FROM THE BALLOON CATHETERS DURING ATTEMPTED DELIVERY THROUGH AN UNKNOWN SIZE / BRAND INTRODUCER SHEATH INTO THE FENESTRATION. THE ENDOPROSTHESIS WAS SUCCESSFULLY RETRIEVED USING A SNARE. THE CASE WAS COMPLETED SUCCESSFULLY USING ADDITIONAL GORE® VBX DEVICES. NO UNINTENTIONAL VESSEL COVERAGE WERE REPORTED. THE FINAL ANGIOGRAPHIC RESULT WAS SATISFACTORY, AND NO ADVERSE IMPACT TO THE PATIENT WAS NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23311682 ↗
• MalfunctionNov 1, 2024Material Rupture; Material Rupture

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A REDUCED PROFILE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED IN THE LEFT RENAL ARTERY IN AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSMAL DISEASE. THE VBX DEVICE WAS ADVANCED THROUGH AN UNKNOWN SIZE AND BRAND INTRODUCER SHEATH OVER A 0.035" ROSENWIRE. REPORTEDLY, THE BALLOON PORTION OF THE VBX DEVICE RUPTURED WHEN INFLATED TO 2 ATM. THE STENT PORTION OF THE VBX DEVICE STAYED IN PLACE AND WAS ABLE TO BE SUCCESSFULLY DEPLOYED IN THE INTENDED LOCATION WITH PTA BALLOON. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588809 ↗
• InjuryOct 1, 2024Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated; Difficult to Remove; Difficult to Advance; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) USED IN THE RENAL ARTERY DURING AN ABDOMINAL AORTIC ANEURYSM (AAA) PROCEDURE USING A COOK FENESTRATED AORTIC GRAFT. IT WAS REPORTED THE FIRST VBX DEVICE WAS DEPLOYED INTO THE RENAL ARTERY WITHOUT DIFFICULTY. THE AORTIC GRAFT WAS THEN DEPLOYED. A 6MM X 29 MM VBX DEVICE WAS ADVANCED ON A 0.035" ROSEN WIRE THROUGH A 7FR MEDTRONIC TOURGUIDE INTRODUCER SHEATH THROUGH AN ALREADY PLACED 14 FR COOK INTRODUCER SHEATH. THE SECOND VBX DEVICE WAS UNABLE TO BE ADVANCED THROUGH THE SHEATHS. WHEN REMOVAL WAS ATTEMPTED THE VBX STENT DISLODGED WITHIN THE INTRODUCER SHEATH. THE PHYSICIAN TRIED UNSUCCESSFULLY TO SECURE THE VBX STENT INSIDE THE INTRODUCER SHEATH FOR REMOVAL. THE 14FR SHEATH WAS ADVANCED AND THE VBX STENT WAS CAPTURED. THE PHYSICIAN TRIED MULTIPLE TIMES TO INSERT A BALLOON INTO THE VBX STENT FOR EXPANSION WITHIN THE SHEATH. CONSEQUENTLY, THE VBX STENT WAS PUSHED OUT OF THE INTRODUCER SHEATH AND THROUGH A SMALL INCISION, THE PHYSICIAN TRIED TO REMOVE THE VBX STENT USING FORCEPS. ULTIMATELY, GUIDEWIRE ACCESS WAS LOST AND THE VBX STENT EMBOLIZED DISTALLY

  Patient problems: Foreign Body Embolism

  MAUDE report 20349254 ↗
• MalfunctionMay 23, 2024Patient-Device Incompatibility; Device Dislodged or Dislocated; Patient-Device Incompatibility; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A FENESTRATED CASE WAS PERFORMED AND COOK AORTIC DEVICES AND GORE AORTIC DEVICES WERE IMPLANTED. ACCESS WAS FROM THE GROIN AREA. AS REPORTED, THE PATIENT HAS A VERY TIGHT, TORTUROUS ANATOMY. A LARGE ANEURYSMAL LEFT HYPOGASTRIC ARTERY ALSO REQUIRED TREATMENT. AN .035 AMPLATZ STIFF WIRE WAS USED FOR ADVANCEMENT OF THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). HOWEVER, THE VBX DEVICE WAS UNABLE TO TRACK INTO THE SHARP ANGLE OF THE HYPOGASTRIC ARTERY. THE WIRE WAS EXCHANGED TO A GLIDEWIRE TO ACCOMMODATE THE TORTUOUS ANATOMY. THE 7X39 VBX DEVICE WAS ADVANCED AGAIN BUT THEN IT BECAME STUCK ON THE GLIDEWIRE. AS THE PHYSICIAN PULLED THE STUCK VBX DEVICE WITH EXTRA FORCE, THE BALLOON AND STENT BROKE OFF INSIDE THE ANEURYSM. THE DELIVERY CATHETER WAS REMOVED. NEXT, A 6X29 VBX DEVICE WAS ADVANCED, BUT IT BECAME IT BECAME STUCK WHEN TRYING TO GET THE DEVICE ACROSS THE ANEURYSM. THE VBX DEVICE WAS PUSHED FIRMLY WHEN IT WEDGED INTO A TURN AND BECAME STUCK INSIDE THE ANEURYSM. AS THE DELIVERY CATHETER WAS PULLED BACK, THE STENT DISLODGED FROM THE BALLOON INSIDE THE ANEURYSM. THE BALLOON AND CATHETER WERE REMOVED THE CONS

  Patient problems: Foreign Body In Patient

  MAUDE report 19388633 ↗
• MalfunctionMay 17, 2024Material Rupture; Activation Failure; Unintended Deflation; Material Rupture; Activation Failure; Unintended Deflation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE PULMONARY ARTERY DURING TREATMENT OF AN ARTERIOVENOUS MALFORMATION. AFTER THE VBX DEVICE WAS SUCCESSFULLY DELIVERED INTO THE PULMONARY ARTERY THE PHYSICIAN FELT RESISTANCE WHEN ATTEMPTING TO REMOVE THE DELIVERY CATHETER. THE PHYSICIAN WAS ABLE TO PUSH THE DELIVERY CATHETER FORWARD BUT STUCK WHEN ATTEMPTING TO REMOVE IT. THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY CATHETER, HOWEVER WHEN HE RAN CONTRAST, THE DEVICE HAD APPEARED TO HAVE BEEN PULLED AWAY FROM THE INTENDED LANDING ZONE (APPROXIMATELY 2CM). THE PHYSICIAN READVANCED THE DELIVERY CATHETER AND INFLATED TO NOMINAL PRESSURE AND WAS ABLE TO GET THE VBX DEVICE BACK INTO POSITION. THE DELIVERY CATHETER WAS SUCCESSFULLY REMOVED. THE DECISION WAS MADE TO EXTEND THE VBX DEVICE WITH AN ADDITIONAL VBX DEVICE. AFTER THE DEVICE WAS SUCCESSFULLY DELIVERED, AND THE PHYSICIAN FELT RESISTANCE ONCE AGAIN DURING THE REMOVAL OF THE SECOND VBX DELIVERY SYSTEM. AFTER ANOTHER CONTRAST RUN, THEY NOTICED THAT THE VBX DEVICES HAD BEEN PULLED BACK APPROXIMATELY 2CM. THE PHYSICIAN READVANCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19346980 ↗

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