GORE VIABAHN VBX Balloon Expandable Endo BXB072901ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132658619), received between Jun 12, 2025 and Jun 12, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Rupture” (2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2025Material Rupture; Material Rupture

  THE FOLLOWING WAS REPORTED TO GORE: ON ()() 2025, A PATIENT WAS TREATED WITH A 4 VESSEL PHYSICIAN MODIFIED ENDOGRAFT. DURING THIS PROCEDURE, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED IN THE RIGHT RENAL ARTERY (RRA). A SECOND VBX DEVICE WAS DEPLOYED IN THE RRA BECAUSE THE FIRST VBX DEVICE DID NOT EXTEND FAR ENOUGH INTO THE AORTA. THE PHYSICIAN REPORTED THAT DURING THE DEVICE DEPLOYMENT, BOTH BALLOONS RUPTURED BEFORE REACHING NOMINAL PRESSURE ON THE IN DEFLATOR DEVICE. AS REPORTED, THE BALLOON STARTED INFLATING FROM BOTH ENDS BUT RUPTURED BEFORE FULL EXPANSION. THE PHYSICIAN USED A MUSTANG¿ BALLOON DILATATION CATHETER TO BALLOON EACH VBX DEVICE TO FULL EXPANSION. BOTH VBX CATHETERS WERE REMOVED INTACT. THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT. THE PHYSICIAN REPORTED HE DOES NOT KNOW WHY THE BALLOONS RUPTURED IN THE SAME ANATOMICAL LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196121 ↗
• MalfunctionJun 12, 2025Material Rupture; Material Rupture

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED WITH A 4 VESSEL PHYSICIAN MODIFIED ENDOGRAFT. DURING THIS PROCEDURE, A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) WAS IMPLANTED IN THE RIGHT RENAL ARTERY (RRA). A SECOND VBX DEVICE WAS DEPLOYED IN THE RRA BECAUSE THE FIRST VBX DEVICE DID NOT EXTEND FAR ENOUGH INTO THE AORTA. IT WAS REPORTED BY THE PHYSICIAN THAT TWO BALLOONS RUPTURED BEFORE REACHING NOMINAL PRESSURE ON THE IN DEFLATOR DEVICE. THE BALLOON STARTED INFLATING FROM BOTH ENDS BUT RUPTURED BEFORE FULL EXPANSION. THE VBX CATHETERS WERE REMOVED INTACT. THE PHYSICIAN THEN INSERTED A MUSTANG¿ BALLOON DILATATION CATHETER AND BALLOONED THE VBX DEVICES TO FULL EXPANSION. THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT. THE PHYSICIAN REPORTED HE DOES NOT KNOW WHY THE BALLOONS RUPTURED IN THE SAME ANATOMICAL LOCATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195865 ↗

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