GORE VIABAHN Endoprosthesis with Heparin VBHR091002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132645985), received between Sep 29, 2021 and Jul 2, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2025Material Invagination; Material Invagination

  THE FOLLOWING WAS REPORTED TO GORE FROM GORE IMAGING: ON (B)(6) 2025, THIS 85-YEAR-OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR REINTERVENTION OF AN ENDOLEAK TYPE 1B. THE PATIENT WAS TREATED WITH A GORE® EXCLUDER®CONFORMABLE AAA ENDOPROSTHESIS AORTIC EXTENDER DEVICE IN THE INFRARENAL ABDOMINAL AORTA, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) IN THE RIGHT EXTERNAL ILIAC ARTERY, AND TWO VSX DEVICES IN THE RIGHT INTERNAL ILIAC ARTERY. THE SITES WERE ACCESSED PERCUTANEOUSLY ON THE RIGHT AND BY CUT-DOWN ON THE LEFT. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATIONS AND SUCCESSFULLY DEPLOYED. THERE WERE NO ACCESS-RELATED COMPLICATIONS. THE PATIENT HAD A MILD STROKE BUT WAS DISCHARGED HOME FROM THE HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD A CT ANGIOGRAM. REVIEW OF THE CT SHOWED AN ENDOLEAK OF INDETERMINATE TYPE ENDOLEAK AND COMPRESSION/INFOLDING RELATED TO VSX REGISTRY DEVICE. ON (B)(6) 2025, THE PATIENT HAD A CT ANGIOGRAM AND WAS NOTED TO HAVE A TYPE 2 ENDOLEAK, AND CONTINUED COMPRESSION/INFOLDING RELATED TO THE VSX REGISTRY DEVICES IN THE RIIA AND REIA. REPORTEDLY THE VSX DEVICES REMAINED PATENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385155 ↗
• InjuryOct 18, 2024Partial Blockage; Partial Blockage

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, TWO GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WERE DELIVERED TO TREAT A POPLITEAL ANEURYSM. ON (B)(6) 2024, THE PATIENT RETURNED TO HOSPITAL WITH THROMBOSED VSX DEVICES. DURING THIS TIME THE PATIENT WAS DIAGNOSED POSITIVE FOR HEPARIN-INDUCED THROMBOCYTOPENIA (HIT). IT WAS REPORTED THAT THE PATIENT DID RECEIVE IV HEPARIN AT THE TIME OF THE PROCEDURE AS WELL. THE PATIENT UNDERWENT MECHANICAL THROMBECTOMY AND LYSIS. THE GRAFT WAS RELINED WITH VSX DEVICES WITHOUT CBAS® HEPARIN SURFACE LINING.

  Patient problems: Stenosis; Thrombocytopenia

  MAUDE report 20483495 ↗
• MalfunctionSep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A POPLITEAL ARTERY ANEURYSM, AN 8FR ANSEL COOK SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) OVER AN .035GLIDEWIRE ADVANTAGE. THE VIABAHN DEVICE WAS IMPLANTED AT THE INTENDED TREATMENT SITE. AFTER DEPLOYMENT, THE DISTAL SHAFT OF THE CATHETER BECAME DETACHED WHILE IT WAS BEING WITHDRAWN. THE PHYSICIAN WAS ABLE TO RETRIEVE THE BROKEN PIECE USING A SNARE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20338644 ↗
• MalfunctionMar 25, 2024Break; Break

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT A THORACIC BRANCH FENESTRATED ENDOGRAFT PROCEDURE WITH BRANCHES IN THE LEFT RENAL ARTERY WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS USED. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT VIA THE GROIN AREA. THE DELIVERY CATHETER WAS ADVANCE THROUGH A COOK 8FR FLEXOR® ANSEL GUIDING SHEATH THAT WAS INSIDE A MEDTRONIC 16FR APTUS SHEATH OVER AN ABBOTT 0.035" TAD¿ GUIDEWIRE. AFTER REACHING THE TARGET TREATMENT AREA WITHOUT AN ISSUE, DEPLOYMENT OF THE VIABAHN DEVICE WAS INITIATED. THE PHYSICIAN WAS DEPLOYING THE VIABAHN DEVICE IN A CURVED TREATMENT AREA SO THEY PERFORMED A SEQUENTIAL DEPLOYMENT ON PURPOSE TO PREVENT BOW STRINGING. AS THE PHYSICIAN WAS APPROACHING THE END OF THE VIABAHN DEVICE'S DEPLOYMENT, IT WAS NOTICED THAT THERE WAS TENSION BEING PULLED AT THE PROXIMAL END OF THE DEVICE. THE VIABAHAN DEVICE WAS DEPLOYED AT THE TARGET TREATMENT AREA. WHEN THE PHYSICIAN WENT TO PULL OUT THE 8FR SHEATH AND THE DELIVERY SYSTEM OUT OF THE APTUS SHEATH THE PHYSICIAN NOTICED THAT THE DISTAL OLIVE TIP MARKER WAS STILL DOWN IN THE RENAL ARTERY. THE CATHETER TIP BROKE OFF A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18972140 ↗
• MalfunctionSep 29, 2021Separation Problem; Material Separation; Separation Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION OF A PREVIOUSLY IMPLANTED AV ACCESS GRAFT IN THE LEG USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE DEVICE WAS ADVANCED AND TO ITS INTENDED LOCATION AND IMPLANTED WITH NO ISSUE. HOWEVER, ONCE THE DEVICE WAS WITHDRAWN IT WAS NOTED THE TIP OF THE CATHETER HAD SEPARATED IN THE PATIENTS LEG. ANOTHER GORE DEVICE WAS USED TO PIN THE TIP OF THE CATHETER TO THE PREVIOUS IMPLANTED GRAFTS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12550986 ↗