GORE VIABAHN VBX Balloon Expandable Endo BXB087902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00733132658763), received between Jun 13, 2024 and May 1, 2026 — classified as 3 injuries, 3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 1, 2026Complete Blockage

  THE FOLLOWING WAS REPORTED FROM A STUDY: ON (B)(6) 2026, A STUDY PATIENT UNDERWENT A THORACOABDOMINAL AORTIC ANEURYSM PROCEDURE. GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) WERE IMPLANTED DURING THIS PROCEDURE. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. DISSECTION IN THE SUPERIOR MESENTERIC ARTERY (SMA) WAS OBSERVED LATER IN THE EVENING POST PROCEDURE. AS REPORTED, THIS WAS PROCEDURE RELATED AND THE DISSECTION WAS CAUSED BY THE GUIDEWIRE. ON (B)(6) 2026, THE SMA DISSECTION FLAP WITH LUMEN THROMBOSIS WAS STENTED WITH A 7X40 INNOVA NITINOL STENT THAT EXTENDED FROM THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) AROUND THE GENU TO TACK UP THE FLAP.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25059176 ↗
• InjuryApr 21, 2026Insufficient Device Problem Information

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A ZONE 5 DESCENDING THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) IN THE SUPERIOR MESENTERIC ARTERY (SMA). ON (B)(6) 2026, THE PATIENT UNDERWENT A REINTERVENTION DUE TO OCCLUSION OF THE SMA STENT. THE ENDOPROSTHESIS IN THE SMA WAS FOUND TO BE OCCLUDED AND WAS 'BENDING' OUT OF THE PORTAL. HOWEVER, IT WAS NOTED THE COLLATERAL VESSELS WERE FILLING, AND THERE WAS A CONCERN REGARDING ADDITIONAL RADIATION EXPOSURE, THEREFORE NO FURTHER INTERVENTION OF THE SMA WAS PERFORMED. NO ADDITIONAL TREATMENT PLAN IS CURRENTLY IN PLACE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 24942357 ↗
• InjuryMay 1, 2025Deformation Due to Compressive Stress; Device Stenosis; Deformation Due to Compressive Stress; Device Stenosis

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). ON (B)(6) 2025, THE PATIENT PRESENTED WITH SLIGHT PAIN. A COMPUTED TOMOGRAPHY SCAN WAS TAKEN, AND IT SHOWED THE LEFT RENAL VBX DEVICE WAS COMPRESSED. PATIENT UNDERWENT REINTERVENTION SURGERY IN WHICH A THROMBECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WERE PERFORMED ON THE COMPRESSED VBX DEVICE. THE VBX DEVICE WAS THEN RELINED WITH A GORE® VIABAHN® ENDOPROSTHESIS DEVICE. PATIENT TOLERATED THE PROCEDURE. NO FURTHER PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Stenosis

  MAUDE report 21942000 ↗
• MalfunctionMar 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: DURING A THORACOABDOMINAL BRANCH ENDOPROSTHESIS PROCEDURE, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS TO BE IMPLANTED IN THE LEFT RENAL ARTERY. USING AN 8FR SHEATH (UNSPECIFIED BRAND), AN 8 X 79 VBX DEVICE WAS ADVANCED TO THE INTENDED TREATMENT SITE. HOWEVER, IT WAS REALIZED THE VBX DEVICE WAS TOO LONG. THE PHYSICIAN WAS PULLING THE DEVICE BACK OUT THROUGH THE SHEATH WHEN THE VBX STENT WAS DISLODGED. A GOOSENECK SNARE WAS USED TO CAPTURE AND REMOVE THE STENT FROM THE PATIENT WITH EASE. A NEW 8 X 59 VBX DEVICE WAS THEN ADVANCED AND DEPLOYED WITH NO ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698400 ↗
• MalfunctionFeb 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) WHERE A REDUCED PROFILE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED IN THE RIGHT INTERNAL ILIAC. IT WAS REPORTED THAT THE VBX DEVICE DISLODGED FROM THE BALLOON WHILE PHYSICIAN WAS PULLING BACK ON AN UNKNOWN BRAND 12X45 SHEATH AND THE STENT SHEARED OFF THE BALLOON. THE STENT STAYED INSIDE THE PATIENT IN THE TERMINAL AORTA. IT WAS REPORTED THAT THE STENT WAS LEFT AS ENDOTRASH SINCE IT WAS NOT DEPLOYED. A NEW VBX DEVICE WAS USED TO COMPLETE THE PROCEDURE. REPORTEDLY, PHYSICIAN SUSPECTS THE ISSUE WAS DUE TO THE EXTREMELY TORTUOUS ANATOMY. IT WAS NOT A SMOOTH TRANSITION DUE TO THE ANATOMY OF THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21397590 ↗
• MalfunctionJun 13, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  THE FOLLOWING WAS REPORTED TO GORE: DURING AN ABDOMINAL ANEURYSM PROCEDURE, TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES (VBX DEVICES) WERE IMPLANTED TO TREAT THE AORTO-ILIAC ARTERIES USING A KISSING TECHNIQUE. AS REPORTED, THE VBX DEVICES REACHED THE INTENDED TREATMENT SITE AND BOTH WERE DEPLOYED WITH NO ISSUES. HOWEVER, WHEN THE VBX BALLOON CATHETER WAS REMOVED FROM THE PATIENT'S LEFT SIDE ACCESS, IT WAS NOTICED THE BALLOON COVERING HAD BECOME DETACHED ON ONE END. THE REMOVED BALLOON WAS CONFIRMED TO HAVE NO MISSING PIECES. IT IS UNKNOWN WHICH BALLOON WAS PARTIALLY DETACHED AS SAME SIZED VBX DEVICES WERE USED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529380 ↗

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