GORE VIABAHN VBX Balloon Expandable Endo BXB083902ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132658725), received between Jul 22, 2024 and Jun 17, 2026 — classified as 1 injury, 3 malfunctions.

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

• MalfunctionJun 17, 2026Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, DURING TREATMENT OF A STENOSIS IN THE CELIAC ARTERY, A 7FR RAABE SHEATH WAS USED TO ADVANCED A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). IT WAS REPORTED THE PHYSICIAN RETRACTED THE VBX DEVICE BACK INTO THE SHEATH BECAUSE IT DID NOT CROSS THE LESION. AS THE VBX DEVICE WAS WITHDRAWN, THE CONSTRAINED DEVICE WAS DISLODGED AFTER CATCHING ON THE EDGE OF THE SHEATH. THE DISLODGED STENT WAS CONFINED AGAINST THE WALL OF THE EXTERNAL ILIAC ARTERY WITH A DEVICE. THEN, A NEW VBX DEVICE WAS ADVANCED AND DEPLOYED WITH NO ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. AS REPORTED, THE PHYSICIAN SUSPECTS THE INNER DIAMETER OF THE RAABE SHEATH WAS ALSO TOO TIGHT FOR THE VBX DEVICE.

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

  MAUDE report 25534693 ↗
• InjuryMay 20, 2026Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2026, A PATIENT WAS TREATED FOR A THORACOABDOMINAL ANEURYSM USING A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE) SYSTEM OF COMPONENTS, INCLUDING GORE® EXCLUDER® AAA ENDOPROSTHESIS DEVICES, A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE, AND GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES. ON (B)(6) 2026, IMAGING SHOWED THAT THE VBX DEVICE IN THE SUPERIOR MESENTERIC ARTERY (SMA) WAS <50% STENOSED. NO TREATMENT WAS TAKEN.

  Patient problems: Stenosis

  MAUDE report 25232208 ↗
• MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON OCTOBER 7, 2025, A PATIENT UNDERWENT A PHYSICIAN-MODIFIED ENDOVASCULAR GRAFT (PMEG) PROCEDURE IN WHICH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS UTILIZED IN THE CELIAC ARTERY. THE SPECIFIC PRIMARY AORTIC COMPONENT USED DURING THE PROCEDURE WAS NOT IDENTIFIED.IT WAS REPORTED DURING THE INTERVENTION, THE VBX DEVICE WAS INITIALLY ADVANCED THROUGH THE FENESTRATION (¿GATE¿) USING A SHEATH. THE SHEATH WAS THEN RETRACTED TO PREPARE THE DEVICE FOR DEPLOYMENT. THE PHYSICIAN MADE TWO POSITIONING ADJUSTMENTS. ON THE SECOND ATTEMPT, WHILE RETRACTING THE DEVICE, THE STENT BECAME HUNG UP ON THE GATE AND SUBSEQUENTLY DISLODGED FROM THE BALLOON CATHETER. THE DISLODGED STENT SETTLED BETWEEN THE ENDOGRAFT AND THE NATIVE VESSEL WALL WITHIN THE AORTIC LUMEN.REPORTEDLY, THE DISLODGED DEVICE POSED NO CLINICAL RISK TO THE PATIENT AND THE VBX DEVICE WAS LEFT IN PLACE WITHIN THE AORTIC SPACE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23413969 ↗
• MalfunctionJul 22, 2024Break; Break

  ON (B)(6) 2024, A PATIENT UNDERWENT A PROCEDURE FOR STENOTIC OCCLUSION WHERE AN 8 MM X 39 MM REDUCED PROFILE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (GORE® VIABAHN® VBX DEVICE) WAS INTENDED TO BE USED IN THE LEFT INTERNAL ILIAC ARTERY. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT USING A 7F UNKNOWN BRAND GUIDING SHEATH OVER AN UNKNOWN BRAND AND SIZE GUIDE WIRE TO THE TARGET TREATMENT ZONE. REPORTEDLY, THE TARGET LESION WAS NOT PRE-DILATED, AND THERE WAS NO UNUSUAL RESISTANCE DURING ADVANCEMENT OF THE DELIVERY CATHETER THROUGH THE SHEATH. DURING DEPLOYMENT OF THE ENDOPROSTHESIS, THE BALLOON WAS INFLATED AT NOMINAL PRESSURE. AFTER MAINTAINING PRESSURE FOR 15 SECONDS THE INFLATION PRESSURE ON THE INFLATION DEVICE STARTED TO DECREASE. THE BALLOON DEFLATED AND THE DELIVERY CATHETER WAS WITHDRAWN. IT WAS REPORTED THE ENDOPROSTHESIS REACHED FULL EXPANSION AND GOOD WALL APPOSITION WAS ACHIEVED. ON THE BACK TABLE THE BALLOON WAS INFLATED AND A PINHOLE ON THE BALLOON WAS NOTICED. IT WAS REPORTED THE GORE® VIABAHN® VBX DEVICE DELIVERY CATHETER DID NOT TRACK THROUGH ANY OTHER DEVICES (I.E., PRE-EXISTING STENT IMPLANTS) DURING THE PROCEDURE. IT IS UNKNOWN IF NEGATIVE PRESSURE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794962 ↗

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