GORE VIABAHN VBX Balloon Expandable Endo BXB077902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132658688), received between Nov 4, 2025 and Sep 30, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Complete Blockage” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Complete Blockage

  Patient problems: Obstruction/Occlusion; Stenosis

  MAUDE report 50955046 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM OF THE DESCENDING THORACIC AORTA. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES WERE USED IN THE VISCERAL ARTERIES. THE PATIENT TOLERATED THE PROCEDURE. THE GORE DEVICES WERE SUCCESSFULLY IMPLANTED. ON (B)(6) 2025, THE PATIENT WAS DISCHARGED HOME. ON (B)(6) 2025, FOLLOW UP CTA IMAGING SHOWED LEFT RENAL SIDE BRANCH STENT STENOSIS (> 75%). ON (B)(6) 2025, AN ENDOVASCULAR REINTERVENTION PROCEDURE WAS PERFORMED FOR LEFT RENAL ARTERY STENT STENOSIS. PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY WAS PERFORMED AND AN 8 MM X 59 MM OMNILINK ELITE VASCULAR BALLOON-EXPANDABLE STENT WAS IMPLANTED.

  Patient problems: Reduced Blood Flow; Stenosis

  MAUDE report 25437532 ↗
• InjuryApr 16, 2026Complete Blockage

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). DURING THE INDEX PROCEDURE THE RIGHT RENAL ARTERY WAS COIL EMBOLIZED. ON (B)(6) 2026, RIGHT RENAL INFARCT WAS IDENTIFIED.

  Patient problems: Stenosis

  MAUDE report 24905048 ↗
• InjuryApr 3, 2026Partial Blockage

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6), 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED WITH THE TAMBE DEVICE. ON AN UNKNOWN DATE, THE RIGHT RENAL ARTERY THROMBOSED POST PROCEDURE AND A REINTERVENTION WAS PERFORMED PLACING A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) DISTALLY IN THE RENAL ARTERY TO TREAT THE OCCLUSION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Stenosis

  MAUDE report 24782285 ↗
• InjuryMar 30, 2026Deformation Due to Compressive Stress; Device Damaged by Another Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, A PATIENT UNDERWENT A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE. DURING THIS PROCEDURE, THE LEFT RENAL ARTERY (LRA) WAS NOT PRE-DILATED. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED SUCCESSFULLY IN THE LRA. ON (B)(6) 2026, THE PHYSICIAN REPORTED THE PROXIMAL LRA WAS FOUND TO BE OCCLUDED. REPORTEDLY, THE LRA HAD A PRE-EXISTING MEDTRONIC ENDURANT STENT. THE VBX DEVICE HAD A V-SHAPE, AND ON IMAGING, IT APPEARED THE VBX STENT WAS CAUGHT ON AN ENDURANT STRUT DURING DEPLOYMENT, CAUSING THE ABNORMAL SHAPED OF THE VBX DEVICE. AS REPORTED, THERE HAS BEEN NO INTERVENTION PERFORMED.

  Patient problems: Reduced Blood Flow; Thrombosis/Thrombus

  MAUDE report 24722943 ↗
• InjuryFeb 26, 2026Partial Blockage

  THE FOLLOWING INFORMATION WAS RECEIVED FROM CLINICAL COMPLAINT SPECIALIST. ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) WERE IMPLANTED WITH THE TAMBE DEVICE. ON (B)(6) 2026, IT WAS REPORTED THAT THERE WAS CONCERN OF THROMBOSIS IN THE RENAL ARTERIES AS THE PATIENT WAS HAVING PAIN. ON (B)(6) 2026 A THROMBECTOMY WAS PERFORMED TO ADDRESS THE CONCERN OF THROMBOSIS IN THE RENAL ARTERIES. THE THROMBOSIS WAS RESOLVED WITHOUT SEQUELAE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24456921 ↗
• InjuryFeb 24, 2026Device Dislodged or Dislocated

  ON (B)(6) 2025, A PATIENT WAS TREATED FOR A THORACOABDOMINAL AORTIC ANEURYSM EXTENDING INTO THE ILIAC ARTERIES. DURING THE PROCEDURE, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WAS USED IN THE RIGHT INTERNAL ILIAC ARTERY. ON (B)(6) 2025, A ONE-MONTH FOLLOW-UP CT SCAN SHOWED A TYPE 1C ENDOLEAK IN THE RIGHT ILIAC ARTERY ANEURYSM SAC DUE TO POOR STENT APPOSITION WITHIN THE INTERNAL ILIAC ARTERY. CONTRAST WAS ALSO NOTED NEAR THE LEFT COMMON ILIAC ARTERY, BUT WAS BELIEVED TO BE FROM THE RIGHT SIDE ENDOLEAK. ON (B)(6) 2026, A REINTERVENTION TOOK PLACE TO PLACE AN ADDITIONAL STENT GRAFT. REPORTEDLY, THE REINTERVENTION SUCCESSFULLY CORRECTED THE ENDOLEAK.

  Patient problems: Clinical Endoleak

  MAUDE report 24435028 ↗
• InjuryNov 4, 2025Activation Failure; Device Endoleak; Activation Failure; Device Endoleak

  THE FOLLOWING INFORMATION WAS REPORTED THROUGH THE AAA 24-01 TAMBE POST APPROVAL STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR PROCEDURE TO TREAT A PARARENAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE PATIENT TOLERATED THE PROCEDURE AND DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, A COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WAS DONE AND AN AORTIC ANEURYSM ENLARGEMENT OF 10MM WAS DETERMINED. ADDITIONALLY, ON (B)(6) 2025, AN ENDOLEAK OF AN UNKNOWN ETIOLOGY WAS DETERMINED. ACCORDING TO DR. (B)(6) THE ENDOLEAK CAUSED THE ANEURYSM ENLARGEMENT. THE SITE UPDATED THE STUDY DATA FOR: ON (B)(6) 2025, A TYPE II ENDOLEAK AND A TYPE IIIC ENDOLEAK WERE DETERMINED. THE PATIENT RECEIVED VASOACTIVE MEDICATIONS PENDING VASCULAR SURGERY CONSULT. ON (B)(6) 2025, THE ADDITIONAL PROCEDURE WAS DONE WHERE DR. (B)(6) DID THE FOLLOWING: STENTED THE SUPERIOR MESENTERIC AND RIGHT RENAL ARTERIES AS WELL AS RETROGRAFTED THE AORTIC SAC ACCESS WITH A STENTING OF RIGHT RENAL WITH GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX) DEVICE AND DID A COIL EMBOLIZATION ON THE INFERIOR MESENTERIC ARTERY (IMA) USING PENUMBRA RUBY COILS. THE

  Patient problems: Clinical Endoleak

  MAUDE report 23467269 ↗

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