GORE VIABAHN VBX Balloon Expandable Endo BXB065902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132658466), received between Sep 4, 2024 and Aug 12, 2026 — classified as 2 deaths, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 12, 2026Deformation Due to Compressive Stress

  The following was reported to Gore:On (b)(6) 2026, a patient underwent an endovascular procedure for abdominal aorta aneurysm treatment. GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) was implanted. GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (VBX devices) were implanted as branch devices in the visceral arteries.As reported, the physician stated a potential kink of the 6mm VBX device in right renal artery was noted post operatively. The patient experienced high blood pressure after the index procedure. This resolved after the patient's first bowel movement. On (b)(6) 2026, the VBX device kink was confirmed and reintervention was performed. The VBX device was relined with a 7mm x 30mm Protege Everflex stent. Result was resolution of the kink. The physician reportedly stated the cause of kink was external compression of the arcuate ligament.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50224083 ↗
• InjuryJul 9, 2026Complete Blockage

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM UTILIZING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE) IN CONJUNCTION WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). AT THE ONE-MONTH FOLLOW-UP VISIT, THE PATIENT PRESENTED WITH SHORTNESS OF BREATH. A COMPUTED TOMOGRAPHY (CT) SCAN PERFORMED ON (B)(6) 2026, REVEALED OCCLUSION OF THE LEFT RENAL ARTERY EXTENDING TO THE PORTAL REGION. SUBSEQUENTLY, THE PHYSICIAN PERFORMED A THROMBECTOMY USING A PENUMBRA CATHETER TO REMOVE THE THROMBUS. THE VBX DEVICE WAS THEN POST-DILATED WITH A 6 MM BALLOON. FOLLOWING THESE INTERVENTIONS, BLOOD FLOW TO THE KIDNEY WAS SUCCESSFULLY RESTORED.

  Patient problems: Stenosis

  MAUDE report 25766124 ↗
• MalfunctionDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A THORACOABDOMINAL BRANCH ENDOPROSTHESIS PROCEDURE WAS PERFORMED, AND A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS WAS IMPLANTED FIRST. THE PHYSICIAN THEN MOVED ON TO THE AORTOILIAC- BILATERAL ANEURYSM TREATMENT. FROM THE GROIN ACCESS, AN ILIAC BRANCH ENDOPROSTHESIS WAS IMPLANTED IN THE RIGHT HYPOGASTRIC ARTERY. USING THE 12 X 45 GORE® DRYSEAL FLEX INTRODUCER SHEATH, A 6 X 59 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS ADVANCED THROUGH THE SHEATH TO THE OSTIUM OF THE HYPOGASTRIC ARTERY. THE VBX DEVICE WAS ADVANCED BUT PUSHABILITY WAS LOST, SO THE VBX DEVICE WAS PULLED BACK. AT THIS TIME IT WAS NOTICED THE VBX STENT HAD DISLODGED FROM THE CATHETER AND FLOATED INTO THE INTERNAL EXTERNAL ARTERY AT THE BIFURCATION. A 7FR ANSEL COOK SHEATH WAS INSERTED INTO 12FR SHEATH, TO BE INSERTED INTO THE HYPOGASTRIC ARTERY. A NEW VBX DEVICE WAS THEN ADVANCED AND DEPLOYED WITH NO ISSUES. THE DISLODGED VBX STENT WAS TRAPPED TO THE PATIENT'S VESSEL WITH ANOTHER DEVICE. THE PROCEDURE WAS COMPLETED WITH GOOD RESULTS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23845942 ↗
• DeathMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT OF AN AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED IN THE RENAL ARTERY. IT WAS REPORTED THAT THE RIGHT RENAL ARTERY WAS CANNULATED AND STENTED WITH A 5MM X 79MM AND 7MM X 39 MM VBX DEVICES, THEN THE LEFT RENAL ARTERY WITH A 5MM X 79MM AND 7MM X 39 MM VBX DEVICES, THEN THE SUPERIOR MESENTERIC ARTERY (SMA) WITH A 6MM X 59MM AND 9MM X 39MM VBX DEVICES AND LAST THE CELIAC ARTERY WITH A 6MM X 59MM VBX DEVICE. THE PROCEDURE FOR THE TAMBE TOOK APPROXIMATELY THREE HOURS. UPON THE FINAL COMPLETION ANGIOGRAM, IT WAS NOTED THAT THE RENAL ARTERIES DID NOT HAVE FLOW. THE PHYSICIAN CANNULATED THE RENAL ARTERIES AND DISCOVERED BOTH RENAL ARTERIES HAD THROMBUS PRESENT. THE PHYSICIAN PREFORMED A THROMBECTOMY WITH PENUMBRA WHERE SHE REESTABLISHED FLOW. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO VISUALIZE THE RENAL ARTERIES TO MAKE SURE THE STENTS WERE NOT CRUSHED. EVERYTHING LOOKED APPROPRIATE VIA IVUS. DURING THIS TIME, THE PHYSICIAN DISCOVERED THAT ANESTHESIA HAD BEEN STRUGGLING KEEPING THE ACTIVATED CLOTTING TIME (ACT) THERAP

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21727219 ↗
• DeathMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT OF AN AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED IN THE RENAL ARTERY. IT WAS REPORTED THAT THE RIGHT RENAL ARTERY WAS CANNULATED AND STENTED WITH A 5MM X 79MM AND 7MM X 39 MM VBX DEVICES, THEN THE LEFT RENAL ARTERY WITH A 5MM X 79MM AND 7MM X 39 MM VBX DEVICES, THEN THE SUPERIOR MESENTERIC ARTERY (SMA) WITH A 6MM X 59MM AND 9MM X 39MM VBX DEVICES AND LAST THE CELIAC ARTERY WITH A 6MM X 59MM VBX DEVICE. THE PROCEDURE FOR THE TAMBE TOOK APPROXIMATELY THREE HOURS. UPON THE FINAL COMPLETION ANGIOGRAM, IT WAS NOTED THAT THE RENAL ARTERIES DID NOT HAVE FLOW. THE PHYSICIAN CANNULATED THE RENAL ARTERIES AND DISCOVERED BOTH RENAL ARTERIES HAD THROMBUS PRESENT. THE PHYSICIAN PREFORMED A THROMBECTOMY WITH PENUMBRA WHERE SHE REESTABLISHED FLOW. INTRAVASCULAR ULTRASOUND (IVUS) WAS USED TO VISUALIZE THE RENAL ARTERIES TO MAKE SURE THE STENTS WERE NOT CRUSHED. EVERYTHING LOOKED APPROPRIATE VIA IVUS. DURING THIS TIME, THE PHYSICIAN DISCOVERED THAT ANESTHESIA HAD BEEN STRUGGLING KEEPING THE ACTIVATED CLOTTING TIME (ACT) THERAP

  Patient problems: Thrombosis/Thrombus

  MAUDE report 21727206 ↗
• InjuryFeb 7, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR INFRARENAL ABDOMINAL AORTIC ANEURYSM. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2024, INTERVENTION USING A SNORKEL/CHIMNEY TECHNIQUE WAS PERFORMED DUE TO A PROXIMAL TYPE I ENDOLEAK. A GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED INTO THE LEFT RENAL ARTERY. THE ENDOLEAK WAS RESOLVED. ON (B)(6) 2025, IMAGING PROVIDED TO GORE FOR EVALUATION SHOWED A PROXIMAL TYPE I ENDOLEAK/GUTTER LEAK. THE LEAK APPEARED TO ORIGINATE AROUND THE VBX DEVICE AT THE LEFT RENAL ARTERY, AND NEAR THE GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS. IMAGING ALSO SHOWED ANEURYSM ENLARGEMENT FROM 5.5 CM TO 6.2 CM. ON (B)(6) 2025, THE PATIENT UNDERWENT REINTERVENTION AND A NEW GORE® EXCLUDER® CONFORMABLE AORTIC EXTENDER ENDOPROSTHESIS WAS IMPLANTED PROXIMALLY TO RESOLVE THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 21337767 ↗
• InjurySep 4, 2024Obstruction of Flow; Patient-Device Incompatibility; Obstruction of Flow; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TAMBE PROCEDURE IN ZONE 5 DESCENDING AORTA TO TREAT A JUXTARENAL ANEURYSM UTILIZING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS. AS BRANCH DEVICES, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS WERE IMPLANTED IN THE VISCERAL ARTERIES. TWO VBX DEVICES WERE IMPLANTED (OVERLAPPED) IN THE LEFT RENAL ARTERY. ON AUGUST 06, 2024, THE FIELD SALES ASSOCIATE (FSA) WAS NOTIFIED BY THE PHYSICIAN THAT THE LEFT RENAL PORTAL OF TAMBE DEVICE HAS THROMBOSED ALONG WITH THE TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS AND LEADING TO THE OCCLUSION OF THE PATIENT'S LEFT RENAL ARTERY. REPORTEDLY, THIS WAS A KNOWN PROBABILITY DUE TO THE ANATOMY OF THE ANEURYSM AS PATIENT'S ANATOMY WAS CHALLENGING AND TORTUROUS. THE OCCLUSION WAS FOUND DURING A POST-OP CT SCAN THAT WAS DONE PRIOR TO DISCHARGE FROM HOSPITALIZATION (DATE UNKNOWN). THE PHYSICIAN IS GOING TO GET A FOLLOW UP CT SCAN DONE IN 6 MONTHS. NO INTERVENTION IS PLANNED AT THIS TIME AND PATIENT IS DOING FINE BUT HAS LOST LEFT KIDNEY FUNCTION. NO DIALYSIS APPEARS TO BE NEEDED AT THIS TIME. VBX DEVICE FAILURE MODE CODE 2203-A:-OTHER (L

  Patient problems: Obstruction/Occlusion; Renal Impairment

  MAUDE report 20140950 ↗

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