GORE VIABAHN VBX Balloon Expandable Endo BXA087902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132637799), received between Nov 9, 2020 and Mar 25, 2025 — classified as 4 injuries.

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

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

• InjuryMar 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, A PATIENT UNDERWENT A THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE USED FOR BRANCH DEVICES. AS REPORTED, THE PROCEDURE WENT WELL WITH TECHNICAL SUCCESS. ON (B)(6) 2024, THE PHYSICIAN REVIEWED THE POST PROCEDURE IMAGES AGAIN AND NOTICED A POSSIBLE SMALL ENDOLEAK. IT APPEARED THE DEVICE PURCHASE IN THE SUPERIOR MESENTERIC ARTERY (SMA) ARTERY MAY NOT HAVE BEEN SUFFICIENT. ON (B)(6) 2024, AN INTERVENTION WAS PERFORMED. THE VBX DEVICE WAS EXTENDED WITH A NEW 8 X 59 VBX DEVICE THE INTERVENTION HAD A GOOD OUTCOME AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21691686 ↗
• InjuryFeb 28, 2023Material Perforation; Appropriate Device Problem Term/Code Not Available; Material Perforation; Appropriate Device Problem Term/Code Not Available

  ON (B)(6) 2022, A STUDY PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM IN THE GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) CLINICAL TRIAL. THE VBX STENTS WERE IMPLANTED AS BRANCH COMPONENTS IN THE CELIAC, SUPERIOR MESENTERIC ARTERY (SMA), LEFT AND RIGHT RENAL ARTERIES. DURING PATIENT FOLLOW-UP VISIT ON (B)(6) 2022, CTA SHOWED A BRISK ENDOLEAK, WHICH LOOKED TO BE ASSOCIATED WITH VBX STENT IN THE SMA AND LIKELY REPRESENTED A TYPE 1C AS THERE WAS LITTLE EXTENSION OF THE VBX STENT INTO THE SMA. AS REPORTED, THE PHYSICIAN STATED THIS WAS A DEFINITIVE LEAK FROM THE VBX MID STENT, SUSPECTED TO BE FROM A FABRIC TEAR OF THE VBX STENT. PATIENT RETURNED FOR TREATMENT ON (B)(6) 2023. ANGIOGRAPHIC FINDINGS SHOWED NO ENDOLEAK DEMONSTRATED IN THE SMA. HOWEVER, GIVEN THE MINIMAL STENT OVERLAP INTO THE SMA, THE VBX STENT WAS EXTENDED WITH A 7X 59MM GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. COMPLETION ARTERIOGRAM DEMONSTRATED NO LEAK. THE ENDOLEAK WAS CONSIDERED RESOLVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 16453315 ↗
• InjuryOct 31, 2022Device Stenosis; Device Stenosis

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A STUDY PATIENT UNDERWENT A AAA PROCEDURE USING A FENESTRATED DEVICE. SEVERAL GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED AS SIDE BRANCHES. ONE VSX DEVICE WAS IMPLANTED IN THE SUPERIOR MESENTERIC ARTERY AS FIRST DISTAL EXTENSION. ON (B)(6) 2022, STENOSIS IN THE SUPERIOR MESENTERIC ARTERY WAS OBSERVED. ON (B)(6) 2022, A BALLOON ANGIOPLASTY AND STENTING WERE COMPLETED DUE TO THE STENOSIS. PATENCY WAS RESTORED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Stenosis

  MAUDE report 15703255 ↗
• InjuryNov 9, 2020Separation Problem; Separation Problem

  ON (B)(6) 2020 A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE IN THE (B)(6) STUDY. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESES WERE UTILIZED IN THE BRANCH VESSELS. ON (B)(6) 2020 IMAGING REVEALED THAT THE TWO VBX DEVICES WHICH WERE DEPLOYED IN THE SUPERIOR MESENTERIC ARTERY HAD BECOME SEPARATED. ON (B)(6) 2020 A REINTERVENTION TO TREAT THE TYPE III ENDOLEAK WAS PERFORMED. AN ADDITIONAL VBX WAS DEPLOYED TO BRIDGE THE SEPARATION AND THE ENDOLEAK WAS CONSIDERED RESOLVED. THE PATIENT TOLERATED THE PROCEDURE . ON (B)(6) 2020 THE PATIENT WAS DISCHARGED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10813680 ↗

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