GORE VIABAHN VBX Balloon Expandable Endo BXB085902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132658749), received between Oct 30, 2024 and Jun 23, 2026 — classified as 2 deaths, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

• MalfunctionJun 23, 2026Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2026, A 7FR SHEATH (UNSPECIFIED BRAND) WAS PLACED IN THE RIGHT BRACHIAL ARTERY TO TREAT A STENOTIC OCCLUSION IN THE BRACHIOCEPHALIC ARTERY. ANGIOGRAPHY AND ULTRASOUND OF THE RIGHT UPPER ARM AND AORTA WERE PERFORMED. A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS TO BE IMPLANTED. AS REPORTED, THE TREATMENT AREA WAS IN A DIFFICULT LOCATION, AND THE VBX DEVICE WAS UNABLE TO CROSS THE LESION. WHEN THE CONSTRAINED VBX DEVICE WAS PULLED BACK, IT GOT CAUGHT ON EDGE OF THE SHEATH AND THE STENT WAS DISLODGED. AS REPORTED, THERE MAY HAVE BEEN SOME DAMAGE (NOT SPECIFIED) TO THE PATIENT'S ARTERY. THE SHEATH WAS THEN UPSIZED TO A 10FR SHEATH (UNSPECIFIED BRAND) AND THE CONSTRAINED STENT WAS REMOVED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Unspecified Vascular Problem

  MAUDE report 25602634 ↗
• 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. IT WAS REPORTED THE DISLODGED VBX DEVICES HAD PROBLEMS TRACKING UP AND OVER A TRANSFEMORAL APPROACH IN THE TAMBE DEVICE. AS REPORTED, THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25540681 ↗
• InjuryJan 9, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT HAD A HISTORY OF UNDERGOING A PROCEDURE IN WHICH A PHYSICIAN MODIFIED GRAFT (PMEG) WAS IMPLANTED. IT WAS REPORTED A NON-GORE STENT WAS ALSO IMPLANTED THE SUPERIOR MESENTERIC ARTERY (SMA) DURING THIS PROCEDURE. IT WAS REPORTED THE PMEG WAS LEAKING INTO THE ANEURYSM. TO ADDRESS THE ANEURYSM GROWTH, PLANS WERE MADE TO USE A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) TO RELINE THE EXISTING MODIFIED GRAFT. ON (B)(6) 2025, THE PATIENT UNDERWENT THE TAMBE PROCEDURE. A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED. IT WAS REPORTED AFTER THE TAMBE AORTIC COMPONENT DEVICE WAS IMPLANTED. DURING CANNULATION OF THE SMA, THE PHYSICIAN INADVERTENTLY CAUSED A DISSECTION WHILE ADVANCING THE GUIDEWIRE INTO THE EXISTING NON-GORE STENT. AS REPORTED, THE DISSECTION WAS COVERED WITH DEPLOYMENT OF THE VBX DEVICE INTO PORTAL OF THE TAMBE DEVICE. THE VBX DEVICE WAS DEPLOYED WITH NO ISSUES. THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUES, AND THE PATIENT TOLERATED THE PROCEDURE IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT DIED DUE TO

  Patient problems: Ischemia

  MAUDE report 24031073 ↗
• InjuryDec 16, 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, DURING A FOLLOW UP, A TYPE IC ENDOLEAK WAS OBSERVED IN THE SUPERIOR MESENTERIC ARTERY. AN INTERVENTION HAS BEEN SCHEDULED FOR (B)(6) 2025.

  Patient problems: Clinical Endoleak

  MAUDE report 23823938 ↗
• MalfunctionSep 11, 2025Premature Separation; Premature Separation

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR STENOSIS WHERE A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS USED IN THE COMMON ILIAC ARTERY. IT WAS REPORTED DURING THE PROCEDURE; THE PHYSICIAN PERFORMED A KISSING ILIAC STENT PLACEMENT USING A GUIDEWIRE (BRAND UNKNOWN) AND A TERUMO INTRODUCER SHEATH (SIZE UNKNOWN). THE PHYSICIAN INITIALLY INSERTED AN 8MM X 29MM VBX DEVICE, FOLLOWED BY AN 8MM X 59MM VBX DEVICE. BOTH DEVICES REACHED THE TARGET TREATMENT AREA, BUT THE INITIAL PLACEMENT LOCATIONS FOR EACH DEVICE ARE UNKNOWN. AFTER PLACEMENT, THE PHYSICIAN OPTED TO EXCHANGE THE TWO DEVICES, BELIEVING THE FIRST DEVICE (8MM X 29MM) WOULD BE A MORE APPROPRIATE LENGTH FOR THE OPPOSITE SIDE. WHILE ATTEMPTING TO REMOVE THE 8MM X 59MM VBX DEVICE, IT BECAME DISLODGED AND MIGRATED INTO THE COMMON ILIAC ARTERY. EFFORTS WERE MADE TO REINSERT THE BALLOON INTO THE UNDEPLOYED STENT, BUT THE STENT CONTINUED TO SHIFT PROXIMALLY AND COULD NOT BE PROPERLY POSITIONED. AT THIS TIME, THE PHYSICIAN INTRODUCED A SECONDARY BALLOON (BOSTON BRAND) WHICH ALLOWED FOR GENTLE REPOSITIONING OF THE STENT. THE STENT WAS THEN SUCCESSFULLY DEPLOYED AT THE INTENDED TREATMENT SITE. IT IS UNCLEAR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23031671 ↗
• DeathJul 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED FROM THE (B)(4) CLINICAL STUDY MANAGER: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) DEVICE SYSTEM. THE MAXIMUM DIAMETER OF THE AORTIC DISEASE WAS 67MM. TWO GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS DEVICES WERE IMPLANTED IN THE PATIENT'S CELIAC ARTERY. IT WAS REPORTED THAT, DURING THE PROCEDURE, THE PATIENT EXPERIENCED A SPLENIC ARTERY RUPTURE. THE PHYSICIAN ATTEMPTED TO REPAIR THE RUPTURE, BUT ULTIMATELY A SPLENECTOMY WAS PERFORMED. THE PATIENT TOLERATED THE PROCEDURE. REPORTEDLY, THE PATIENT EXPERIENCED COMPLICATIONS POST PROCEDURE, INCLUDING LIVER SHOCK, AND CONTINUED TO DECLINE. THE PATIENT WAS PLACED ON COMFORT CARE. ON (B)(6) 2025, THE PATIENT EXPIRED. DURING THE AUTOPSY ON (B)(6) 2025, THE SITE EXPLANTED THE TAMBE DEVICE SYSTEM. THE EXPLANTED DEVICE SYSTEM WAS RETURNED. IT WAS NOTED THAT THE DEVICE EXPLANT WAS NOT REPORTEDLY RELATED TO AN ALLEGATION AGAINST THE DEVICE SYSTEM, BUT THAT THE EXPLANT WAS PERFORMED DURING THE ALREADY PLANNED AUTOPSY PROCEDURE.

  Patient problems: Internal Organ Perforation; Rupture

  MAUDE report 22399009 ↗
• DeathJun 11, 2025Difficult to Remove; Difficult to Remove

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR AORTOILIAC OCCLUSIVE DISEASE IN THE DISTAL AORTA, BILATERAL COMMON AND EXTERNAL ILIAC ARTERIES. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES WERE IMPLANTED IN THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN BEGAN WITH FEMORAL ENDARTERECTOMY OF THE COMMON FEMORAL ARTERIES. AFTER COMPLETION OF THE ENDARTERECTOMY, BILATERAL ACCESS WAS GAINED AND CORDIS 8 FR BRITE TIP® INTRODUCER SHEATHS WERE INSERTED. THE LESIONS WERE CROSSED; HOWEVER, THE PHYSICIAN ENCOUNTERED A SUBINTIMAL POSITION AT THE DISTAL AORTA. INITIALLY, A COOK MEDICAL BEBACK CROSSING CATHETER WAS ATTEMPTED TO BE USED. A PHILIPS PIONEER PLUS IVUS-GUIDED CATHETER WAS SELECTED FOR RE-ENTRY INTO THE DISTAL AORTA. TWO 8X79 VBX DEVICES WERE DEPLOYED BILATERALLY INTO THE DISTAL AORTA AND COMMON ILIAC ARTERIES USING A KISSING STENT TECHNIQUE. TO EXCLUDE THE AORTIC DISEASE, THE VBX DEVICES WERE SLIGHTLY RAISED IN THE BIFURCATION. TO PRESERVE THE HYPOGASTRIC ARTERY, AN 8X60 BOSTON SCIENTIFIC INNOVA¿ VASCULAR SELF-EXPANDING STENT SYSTEM (INNOVA STENT) WAS DEPLOYED INTO THE 8X79 VBX DEVICE THAT WAS IMPLANTED ON THE RIGHT SIDE. THE INNOVA STENT WAS OVERLAPPED WITH

  Patient problems: Perforation of Vessels

  MAUDE report 22189313 ↗
• MalfunctionOct 30, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024 A 8 MM X 59 MM REDUCED PROFILE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS INTENDED FOR USE IN THE LEFT COMMON ILIAC ARTERY (LCIA) FOR VESSEL OCCLUSION. THE PHYSICIAN ADVANCED THE VBX DEVICE OVER A 0.035" COMMAND GUIDEWIRE THROUGH AN UNKNOWN BRAND/SIZE INTRODUCER SHEATH. IT WAS NOTED THAT THE 8 MM X 59 MM VBX DEVICE WAS TOO LONG. THE PHYSICIAN THEN ATTEMPTED TO RETRACT THE VBX DEVICE INTO THE INTRODUCER SHEATH TO REMOVE THE DEVICE. DURING RETRACTION OF THE VBX DEVICE DELIVERY SYSTEM THE STENT PREMATURELY SEPARATED FROM THE CATHETER AND DISLODGED IN THE LEFT EXTERNAL ILIAC ARTERY (LEIA). THE 8 MM X 59 MM VBX DEVICE WAS BALLOONED AND LEFT IN THE LEIA AS ENDOTRASH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 8 MM X 39 MM VBX DEVICE IMPLANTED IN THE LCIA. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 20568394 ↗

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