GORE VIABAHN VBX Balloon Expandable Endo BXB063902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132658442), received between Jan 16, 2025 and Jun 17, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: DURING A THORACOABDOMINAL ENDOVASCULAR (TAMBE) PROCEDURE ON (B)(6) 2026, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED IN THE VISCERAL ARTERIES AS BRANCH DEVICES. ACCESS WAS MADE FROM THE GROIN AREA. IT WAS REPORTED THAT A 7FR COOK ANSEL SHEATH WAS PLACED INSIDE AN 8FR TOURGUIDE¿ STEERABLE SHEATH. AS THE 8X59 VBX DEVICE WAS ADVANCED INTO THE SUPERIOR MESENTERIC ARTERY, THE VBX DEVICE DISLODGED FROM THE CATHETER. THE PHYSICIAN WAS ABLE TO INSERT A SECONDARY BALLOON THAT WAS SLIGHTLY INFLATED INTO THE VBX DEVICE. USING THE BALLOON THE VBX DEVICE WAS PLACED AT THE INTENDED LOCATION AND DEPLOYED WITH NO ISSUES. USING THE SAME SHEATHS, A 7X29 VBX DEVICE WAS IMPLANTED DISTALLY. NEXT, THE 6X39 VBX DEVICE WAS BEING ADVANCED INTO THE LEFT RENAL ARTERY. HOWEVER, THE VBX DEVICE DISLODGED FROM THE CATHETER. USING THE SAME TECHNIQUE, A SECONDARY BALLOON WAS USED TO PUSH THE VBX DEVICE INTO PLACE AND IT WAS DEPLOYED WITH NO ISSUES. IT WAS REPORTED BOTH OF THE DISLODGED VBX DEVICES HAD PROBLEMS TRACKING UP AND OVER A TRANSFEMORAL APPROACH IN THE TAMBE DEVICE. IT WAS REPORTED THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540677 ↗
• InjuryNov 20, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A TYPE IC ENDOLEAK. A GORE® VIABAHN® ENDOPROSTHESIS WAS IMPLANTED TO TREAT THE ENDOLEAK AS THE LEFT RENAL ARTERY STENT EXTENSION.

  Patient problems: Clinical Endoleak

  MAUDE report 23606525 ↗
• InjuryMar 15, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR A SPLENIC ARTERY ANEURYSM. ACCESS WAS FROM THE ARTERY VIA THE RADIAL APPROACH FROM THE WRIST. A 6FR TERUMO RADIAL SHEATH WAS USED TO ADVANCE A REDUCED PROFILE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) OVER A SUPRA CORE GUIDEWIRE. IT WAS REPORTED THAT DURING THE PROCEDURE, PHYSICIAN ENCOUNTERED DIFFICULTY DEPLOYING A 6MM X 39MM VBX DEVICE/STENT DUE TO THE PATIENT'S TORTUOUS ANATOMY. THE PHYSICIAN-MAINTAINED PRESSURE AT THE NOMINAL LEVEL FOR ABOUT 20 SECONDS BEFORE SLOWLY DEFLATING THE BALLOON. WHEN PUSHED FORWARD, THE BALLOON SEPARATED FROM THE VBX DEVICE/STENT. THE CATHETER WAS THEN PULLED BACK WITH SOME FORCE, CAUSING THE SHEATH TO ADVANCE FORWARD. INITIALLY, IMAGING APPEARED NORMAL; HOWEVER, A SECOND IMAGE FROM A DIFFERENT ANGLE REVEALED BLEEDING BETWEEN THE VBX DEVICE/STENT AND THE SHEATH, SUGGESTING A POSSIBLE PERFORATION. THE PHYSICIAN SUSPECTED THE BLEEDING MAY HAVE BEEN CAUSED BY THE FORCEFUL RETRACTION OF THE DELIVERY CATHETER DUE TO PATIENT'S TORTUOUS ANATOMY. REPORTEDLY, THE STICTION HAD ALREADY BEEN RESOLVED PRIOR TO THE PERFORATION. AFTER THE DELIVERY CATHETER WITH BALLOON WERE REMOVED, TWO

  Patient problems: Perforation of Vessels

  MAUDE report 21613116 ↗
• InjuryJan 16, 2025Fracture; Fracture

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATMENT FOR A STENOTIC OCCLUSION IN THE SUPERIOR MESENTERIC ARTERY. ACCESS WAS MADE FROM THE RIGHT GROIN. A 7FR TOURGUIDE SHEATH WAS USED TO ADVANCE THE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) OVER A BENTSON WIRE TO THE INTENDED TREATMENT SITE. THE VBX DEVICE DEPLOYED FINE AND WAS POST DILATED USING AN 8 X 2 BALLOON (UNSPECIFIED BRAND). ON (B)(6) 2025, THE PHYSICIAN REPORTED THE POST-PROCEDURE IMAGES APPEARED TO INDICATE A VBX STENT FRACTURE. THEREFORE, A NEW VBX DEVICE WAS IMPLANTED THAT SAME DAY TO RELINE THE EXISTING VBX DEVICE. THE PATIENT IS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21173032 ↗

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