GORE VIABAHN VBX Balloon Expandable Endo BXB087901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132658756), received between Jul 25, 2025 and Jun 27, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Deformation Due to Compressive Stress” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2026Deformation Due to Compressive Stress

  ON (B)(6) 2026, THE PATIENT UNDERWENT A COVERED ENDOVASCULAR RECONSTRUCTION OF THE AORTIC BIFURCATION (CERAB) PROCEDURE UTILIZING GORE® VIABAHN® VBX BALLOON-EXPANDABLE ENDOPROSTHESES (VBX DEVICES) DEVICES. DURING LESION PREPARATION, PRE-DILATION WAS PERFORMED USING A 7¿8 MM SHOCKWAVE INTRAVASCULAR LITHOTRIPSY (IVL) DEVICE. THE BALLOON REPORTEDLY RUPTURED DURING USE, LIKELY DUE TO THE PRESENCE OF HEAVILY CALCIFIED STENOTIC DISEASE. THE VBX DEVICE DELIVERY SYSTEMS WERE ADVANCED VIA BILATERAL FEMORAL ACCESS SITES USING 7F AND 8F COOK FLEXOR ANSEL INTRODUCER SHEATHS OVER A 0.035" TERUMO GLIDEWIRE ADVANTAGE® HYDROPHILIC COATED GUIDEWIRE TO THE TARGET TREATMENT SITES. THREE ENDOPROSTHESES WERE SUCCESSFULLY DELIVERED AND DEPLOYED WITHOUT REPORTED COMPLICATIONS. THE 11 MM VBX DEVICE IN THE AORTA WAS POST-DILATED TO 16 MM TO OPTIMIZE APPOSITION. THE BILATERAL 8 MM ILIAC KISSING VBX STENTS WERE NOT POST-DILATED. ALL BALLOONS DEFLATED AS INTENDED, AND THE DELIVERY SYSTEMS WERE WITHDRAWN WITHOUT RESISTANCE OR BALLOON STICTION. INTRAVASCULAR ULTRASOUND (IVUS) DEMONSTRATED ADEQUATE EXPANSION AND LUMINAL PATENCY AT THE COMPLETION OF THE PROCEDURE. HEMOSTASIS WAS ACHIEVED USING A TERUMO ANGIO-SEAL

  Patient problems: Stenosis

  MAUDE report 25645954 ↗
• InjuryDec 15, 2025Device Endoleak; Device Endoleak

  THE FOLLOWING WAS REPORTED FROM A STUDY: ON (B)(6) 2025, A STUDY PATIENT WAS TREATED FOR A COMMON ILIAC ARTERY ANEURYSM IN AN IBE PROCEDURE. DURING THE PROCEDURE, A GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS INTERNAL ILIAC COMPONENT (IBE-IIC) AND A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WERE IMPLANTED IN AN OVERLAPPED FASHION IN THE PATIENT'S LEFT HYPOGASTRIC ARTERY. AN ADJUNCTIVE PROCEDURE WAS ALSO PERFORMED: EMBOLIZATION USING COILS. ON (B)(6) 2025, AN INTERVENTION WAS PERFORMED DUE TO A TYPE IIIB ENDOLEAK. A VBX DEVICE WAS IMPLANTED IN THE LEFT HYPOGASTRIC ARTERY TO EXCLUDE THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Clinical Endoleak

  MAUDE report 23811653 ↗
• InjuryJul 25, 2025Partial Blockage; Partial Blockage

  THE FOLLOWING WAS REPORTED TO GORE ON JULY 8, 2025, FROM THE IMAGING DATABASE: THE FOLLOWING DESCRIPTION SUMMARY WAS PROVIDED FROM INFORMATION EXTRACTED FROM THE CSD BY THE CCS TEAM: ON (B)(6) 2025, THIS 68-YEAR-OLD MALE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS A PLANNED ENDOVASCULAR PROCEDURE FOR AN AORTOILIAC ANEURYSM. THE PATIENT WAS TREATED WITH TWO GORE® EXCLUDER® ENDOPROSTHESIS DEVICES AND THREE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE). THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATIONS AND SUCCESSFULLY DEPLOYED. THE SITES WERE ACCESSED PERCUTANEOUSLY. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED AFTER SUCCESSFUL ACCESS, DELIVERY AND DEPLOYMENT OF THE DEVICES. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2025. ON (B)(6) 2025, IT WAS NOTED THE PATIENT HAD A CTA. THERE IS NO LOSS OF PATENCY NOTED. IT IS NOTED BY IMAGINING THAT THERE IS DEVICE INFOLDING OR COMPRESSION OF THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS (IBC). IT IS ALSO NOTED THAT THERE IS MILD THROMBUS PRESENT IN THE VBX DEVICES IN THE RCI AND RIIA. (B)(6): -OTHER USED TO CAPTURE THROMBOSIS.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22612666 ↗

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