GORE VIABAHN VBX Balloon Expandable Endo BXB075902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132658664), received between Nov 13, 2024 and Aug 6, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Complete Blockage” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• OtherAug 6, 2026Partial 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, a suspected left kidney embolism was identified, which was then confirmed one day postop. Subsequently, the patient experienced left renal artery stent thrombosis, due to mural thrombus from the aneurysm embolizing the left renal artery. The patient was placed on anticoagulation therapy to prevent further thrombosis.FMAR code 2203 - other, used to capture thrombosis.

  Patient problems: Obstruction/Occlusion

  MAUDE report 50159468 ↗
• InjuryJul 30, 2026Device Stenosis; Device Endoleak

  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 Device) devices were used in the visceral arteries. The patient tolerated the procedure. The Gore devices were successfully implanted.¿It was reported that on (b)(6) 2026, an Endoleak- indeterminate, but likely Type II was noted. On (b)(6) 2026 a CT (Computed Tomography) / CTA (Computed Tomography Angiography) was performed. It was noted there was a persistent indeterminate endoleak around the right renal artery, most consistent with a type 1c endoleak. The patient will require an angiogram with possible endovascular intervention.

  Patient problems: Clinical Endoleak; Stenosis

  MAUDE report 50092771 ↗
• InjuryJul 15, 2026Complete Blockage

  ON (B)(6) 2024, A PATIENT UNDERWENT A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) PROCEDURE. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES, MEASURING 7 MM X 59 MM, WERE IMPLANTED IN THE LEFT RENAL ARTERY. FOLLOWING THE INDEX PROCEDURE, THE PATIENT REPORTEDLY LEFT THE HOSPITAL AGAINST MEDICAL ADVICE (AMA) AND DID NOT TAKE PRESCRIBED PLAVIX (CLOPIDOGREL). ON (B)(6) 2024, THE PATIENT RETURNED WITH PAIN AND UNDERWENT A REINTERVENTION PROCEDURE. DURING THE PROCEDURE, A CLOT WAS IDENTIFIED WITHIN A LEFT RENAL ARTERY VBX DEVICE. ACCORDING TO THE PHYSICIAN, THE THROMBOTIC EVENT WAS BELIEVED TO BE ASSOCIATED WITH THE PATIENT'S FAILURE TO TAKE PRESCRIBED PLAVIX THERAPY. IT WAS NO STENOSIS PRESENT. THE AFFECTED LEFT RENAL ARTERY VBX DEVICE WAS RELINED WITH ADDITIONAL VBX DEVICE(S). THE PROCEDURE WAS REPORTEDLY WELL TOLERATED, AND THE REPORTER INDICATED THE INTERVENTION WAS SUCCESSFUL. THE LEFT RENAL ARTERY WAS REPORTED AS PATENT FOLLOWING TREATMENT, AND NO KNOWN RESIDUAL ADVERSE OUTCOMES WERE REPORTED AT THE TIME OF THE COMPLAINT.

  Patient problems: Pain; Thrombosis/Thrombus

  MAUDE report 25830533 ↗
• 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 24905068 ↗
• InjuryApr 8, 2026Complete Blockage

  THE FOLLOWING WAS REPORTED VIA (B)(6) STUDY: ON (B)(6) 2025, THE PATIENT UNDERWENT A PARARENAL ANEURYSM ENDOVASCULAR PROCEDURE USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. DURING THIS PROCEDURE, GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED AS BRANCH DEVICES IN THE VISCERAL ARTERIES. IT WAS REPORTED THE PATIENT'S LEFT RENAL ARTERY WAS PLUGGED DURING THIS PROCEDURE. A PREPLANNED PROCEDURE WAS ALSO PERFORMED. A SELF-EXPANDING STENT GRAFT (UNKNOWN MANUFACTURER) WAS IMPLANTED IN THE PATIENT'S LEFT SUBCLAVIAN ARTERY. DURING PATIENT'S FOLLOW-UP ON (B)(6) 2026, CTA PERFORMED SHOWED THE RIGHT RENAL ARTERY WAS PATENT WITH NO STENOSIS PRESENT. ON (B)(6) 2026, THE PATIENT PRESENTED WITH AN OCCLUDED RIGHT RENAL ARTERY. AS REPORTED, INTERVENTION ATTEMPTS WERE MADE THE SAME DAY. ON (B)(6) 2026, THE PATIENT EXPIRED DUE TO CARDIAC ARREST FROM MULTISYSTEM ORGAN FAILURE. THE PHYSICIAN STATED THE VBX DEVICES DID NOT CONTRIBUTE TO THE PATIENT'S DEATH.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 24823886 ↗
• InjuryMar 13, 2026Device Endoleak

  ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. IT WAS NOTED THAT THE PATIENT'S LEFT RENAL ARTERY WAS COIL EMBOLIZED AS PLANNED DUE TO PREEXISTING OCCLUSION. MULTIPLE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICES) DEVICES WERE IMPLANTED IN THE VISCERAL VESSELS, BRANCHING OFF THE TAMBE PORTALS. ON FINAL COMPLETION ANGIOGRAPHY, A TYPE IIIC ENDOLEAK WAS OBSERVED FROM THE LEFT RENAL ARTERY PORTAL WHERE THE AMPLATZ PLUGS WERE UTILIZED AS PLANNED. ON (B)(6) 2025, A REINTERVENTION WAS PERFORMED TO TREAT THE TYPE IIIC ENDOLEAK. CANNULATION OF THE LEFT RENAL PORTAL WAS ATTEMPTED BUT WAS UNSUCCESSFUL AFTER NUMEROUS ATTEMPTS. THE PROCEDURE WAS TERMINATED AND THE ENDOLEAK IS ONGOING.

  Patient problems: Clinical Endoleak

  MAUDE report 24595822 ↗
• InjuryDec 5, 2025Partial Blockage; Partial Blockage

  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 THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT ON (B)(6) 2025, A TYPE IV ENDOLEAK WAS DETERMINED ATTRIBUTED TO THE STUDY DEVICE. NO TREATMENT WAS REQUIRED. ON (B)(6) 2025, THE ENDOLEAK RESOLVED WITHOUT SEQUELAE. ON (B)(6) 2025, AN ACUTE KIDNEY INJURY WAS NOTICED, AND THE PATIENT HAD FLUID THERAPY. ADDITIONALLY, A RIGHT RENAL ARTERY OCCLUSION WAS NOTED. NO TREATMENT WAS REQUIRED. ACCORDING TO THE SITE, THESE COMPLICATIONS WERE PROCEDURE RELATED. ON (B)(6) 2025, LEUKOCYTOSIS WAS NOTICED. UNKNOWN RELATIONSHIP. NO TREATMENT WAS REQUIRED. ADDITIONALLY, THE PATIENT EXPERIENCED A WORSENING BACK PAIN, AND THE FOLLOWING TREATMENT WAS RECEIVED: FENTANYL IV, OXYCODONE, ACETAMINOPHEN, LIDOCAINE PATCH AND HEATING PAD. ON (B)(6) 2025, AN ACUTE POSTHEMORRHAGIC ANEMIA WAS NOTED AND THE PATIENT UNDERWENT TRANSFUSION PROCEDURE USING PACKED RED BLOOD CELLS 330ML AND 372ML. ON (B)(6) 2025, PLATELETS 240ML TRANSFUSION

  Patient problems: Renal Impairment

  MAUDE report 23730417 ↗
• InjurySep 16, 2025Device Stenosis; Device Stenosis

  ON (B)(6) 2025, THIS 82-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACOABDOMINAL ANEURYSM IV. THE PATIENT WAS TREATED WITH FIVE VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES (VBX DEVICES), THE SITES WERE ACCESSED PERCUTANEOUSLY. THERE WERE NO ADDITIONAL PROCEDURES. THERE WAS NO TYPE I OR TYPE III ENDOLEAKS NOTED AT THE END OF THE PROCEDURE. ON (B)(6) 2025, IT WAS NOTED THERE WAS A RIGHT RENAL STENT GRAFT THROMBOSIS. REPORTEDLY, BOTH VBX DEVICES IN THE RIGHT RENAL ARTERY ARE THROMBOSED. THE EVENT IS NOTED TO BE ONGOING. HOSPITALIZATION WAS REQUIRED FOR THIS ADVERSE EVENT. NO REINTERVENTION OR TREATMENT IS PLANNED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 23069391 ↗
• InjuryJun 20, 2025Complete Blockage; Complete Blockage

  ON (B)(6) 2024, PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A ZONE 5 DESCENDING THORACIC AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES. THE VBX DEVICES WERE IMPLANTED IN SUPERIOR MESENTERIC ARTERY, CELIAC ARTERY, LEFT AND RIGHT RENAL ARTERIES. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2025, THE PHYSICIAN REPORTED THE PATIENT'S LEFT RENAL ARTERY WAS OCCLUDED AT THE JUNCTION WHERE THE TAMBE (PORTALS OF AORTIC COMPONENT) AND VBX DEVICE MEET AND ENTER THE LEFT RENAL ARTERY (LRA). THE LRA IS REPORTED TO BE FULLY THROMBOSED. THE PATIENT IS ON ANTICOAGULANTS; NO RE-INTERVENTION IS PLANNED AT THIS TIME. IT IS UNKNOWN IF BOTH VBX DEVICES OCCLUDED OR JUST THE ONE AT THE PORTAL JUNCTION. REPORTEDLY, THROMBUS WAS NOT AN ISSUE AT THE TIME OF THE IMPLANT. CURRENTLY, THERE IS NO ADDITIONAL INFORMATION ON WHAT THE PHYSICIAN BELIEVES MAY HAVE LED TO THE COMPLETE THROMBOSIS OF THE LEFT RENALS. THERE IS NO FURTHER INFORMATION AT THIS TIME REGARDING PATIENT STATUS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22298815 ↗
• InjuryMar 31, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT AN ENDOVASCULAR TAMBE PROCEDURE TO TREAT AN ANEURYSM UTILIZING GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS, GORE® EXCLUDER® AAA ENDOPROSTHESIS AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. ON (B)(6) 2025, THE PATIENT UNDERWENT A REINTERVENTION PROCEDURE AS THERE WAS CONTRAST IN THE ANEURYSM SAC, BUT PHYSICIAN COULD NOT DETERMINE IF IT WAS A TYPE 2 ENDOLEAK FROM THE LUMBAR ARTERIES OR A LEAK FROM THE LEFT RENAL ARTERY. THEN AN ANGIO WAS PERFORMED BUT THE CAUSE OF THE CONTRAST WAS STILL UNDETERMINED AS IT WAS IN THE AREA OF THE LEFT RENAL ARTERY. THE LEFT RENAL STENTS DID HAVE ADEQUATE LENGTH AND WERE SIZED APPROPRIATELY WITH ADEQUATE OVERLAP FROM THE ORIGINAL PROCEDURE. THE PHYSICIAN DECIDED TO RE-LINE THE LEFT RENAL VIABAHNS (BXB067902A AND BXB075902A) WITH AN ADDITIONAL BXB067902A STENT AND PLACE IT A LITTLE DEEPER INTO THE RENAL WITH MORE OVERLAP. PATIENT IS DOING OKAY. THE CONTRAST DENSITY IN THE SAC WAS REDUCED, HOWEVER, PHYSICIAN STATED THAT THEY WON¿T KNOW WITH CERTAINTY UNTIL THE 30-DAY FOLLOW UP CT SCAN IS PERFORMED.

  Patient problems: Clinical Endoleak

  MAUDE report 21733612 ↗
• MalfunctionNov 13, 2024Difficult or Delayed Separation; Difficult or Delayed Separation

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF THE PATIENT'S ILIAC ARTERY ON (B)(6) 2024, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE/STENT) WAS DEPLOYED WITH NO ISSUES. HOWEVER, THE BALLOON COULD NOT BE DEFLATED AND WAS STILL ATTACHED TO THE EXPANDED STENT. THE PHYSICIAN COULD SEE THE STENT MOVING WHEN ATTEMPTING TO MANEUVER THE BALLOON. ANY RESIDUAL CONTRAST WAS REMOVED FROM THE BALLOON, THEN MULTIPLE TECHNIQUES WERE ATTEMPTED TO DEFLATE THE BALLOON. FINALLY, THE PHYSICIAN JUST USED EXTRA FORCE TO PULL THE BALLOON OUT OF THE ACCESS SITE. AS REPORTED, THE VBX STENT REMAINED IN THE INTENDED TREATMENT LOCATION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675807 ↗

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