GORE VIABAHN Endoprosthesis with Heparin VBHR080501ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132623105), received between Jun 6, 2022 and Aug 4, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (1 report).

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.

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.

• InjuryAug 4, 2026Insufficient Device Problem Information

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132769 ↗
• InjuryAug 21, 2025Obstruction of Flow; Obstruction of Flow

  ON (B)(6) 2024, PATIENT UNDERWENT AN ENDOVASCULAR REPAIR OF THE JUXTA RENAL AORTIC ANEURYSM UTILIZING AN 8 MM X 5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) IN THE LEFT RENAL ARTERY. ON (B)(6) 2025, PATIENT WAS PRESENTED WITH BILATERAL RENAL ARTERY STENT THROMBOSIS, APPROXIMATELY 10 MONTHS AFTER THE ENDOVASCULAR REPAIR OF THE JUXTA RENAL AORTIC ANEURYSM. NO PREDISPOSING FACTOR AND PATIENT IS ON ACUTE RENAL FAILURE REQUIRING DIALYSIS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 22861604 ↗
• MalfunctionAug 4, 2023Activation Failure; Material Split, Cut or Torn; Activation Failure; Material Split, Cut or Torn

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED FOR USE IN AN UNKNOWN ANATOMICAL LOCATION FOR AN UNKNOWN ETIOLOGY. ON (B)(6) 2023, W.L. GORE & ASSOCIATES WERE MADE AWARE OF A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) THAT WAS RETURNED TO THE GORE HISTOLOGY DEPARTMENT. THE DEVICE THAT WAS OBSERVED TO HAVE A BROKEN DEPLOYMENT LINE AND PARTIAL DEPLOYMENT (DISTAL EXPANSION), REPORTED TO HAVE OCCURRED WITHIN THE PATIENT DURING THE INITIAL PROCEDURE ON (B)(6) 2023. THE VIABAHN DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ISSUE, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 8MMX5CM VIABAHN DEVICE. THERE WERE NO REPORTED CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 17466898 ↗
• InjuryJun 6, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON DECEMBER 2, 2021, A GORE® INTERING® VASCULAR GRAFT WAS INTENDED FOR HEMODIALYSIS TREATMENT. ON (B)(6) 2022, THE PATIENT PRESENTED WITH SEROMA. A GORE® INTERING® VASCULAR GRAFT WAS SEWN IN AS A INTERPOSITION GRAFT. ON (B)(6) 2022, THE PATIENT PRESENTED WITH SEROMA. A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS ENDOVASCULARLY PLACED TO RELINE THE SECOND GORE® INTERING® VASCULAR GRAFT, FOR TREATMENT OF ULTRAFILTRATION. ULTRAFILTRATION WAS IDENTIFIED DURING THE PROCEDURE AFTER THE VSX DEVICE WAS SUCCESSFULLY IMPLANTED. ON (B)(6) 2022, THE GORE® INTERING® VASCULAR GRAFT, AND VSX DEVICE WERE EXPLANTED. OTHER CODE (POST-OPERATIVE FLUID LEAKAGE THROUGH VSX DEVICE WALL AFTER ESTABLISHMENT OF BLOOD FLOW).

  Patient problems: Hematoma

  MAUDE report 14604368 ↗