GORE VIABAHN Endoprosthesis with Heparin VBHR080502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132623303), received between Oct 22, 2019 and Aug 14, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Material Separation” (2 reports).

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.

• MalfunctionAug 14, 2026Activation Failure; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50255607 ↗
• InjuryAug 14, 2025Complete Blockage; Complete Blockage

  THE FOLLOWING WAS REPORTED TO GORE ON NOVEMBER 27, 2024, FROM THE IMEDIDATA STUDY DATABASE FOR THE TGR23-02AA TOGETHER AORTIC REGISTRY. ON (B)(6) 2024, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT AS AN ELECTIVE PROCEDURE FOR A RIGHT ILIAC ARTERY ANEURYSM USING A GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS DEVICE SYSTEM, A GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER COMPONENT, AND A GORE® VIABAHN® ENDOPROSTHESIS. THE SITES WERE ACCESSED PERCUTANEOUSLY BILATERALLY. THE DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATION AND DEPLOYED WITH NO REPORTED ISSUES. DEVICE CATHETERS WERE SUCCESSFULLY REMOVED. THERE WERE NO REPORTED ISSUES. THE PATIENT WAS DISCHARGED TO HOME ON (B)(6) 2024. ON (B)(6) 2024, IT WAS REPORTED THAT THE RIGHT EXTERNAL ILIAC ARTERY HAD THROMBOSED LEADING TO OCCLUSION AND ISCHEMIA. THE GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS ILIAC BRANCH COMPONENT (CEB) AND GORE® EXCLUDER® CONFORMABLE AAA AORTIC EXTENDER COMPONENT (PLA) WERE IMPLANTED IN THE PATIENT'S RIGHT EXTERNAL ILIAC ARTERY. AFTER ADDITIONAL REVIEW OF THE FOLLOW-UP IMAGING DATED (B)(6) 2024, COMPRESSION OF THE CEB DEVICE WAS OBSERVED. LOSS OF DEVICE PATENCY WAS CONFIRMED IN THE CEB AND PLA AND W

  Patient problems: Obstruction/Occlusion; Thrombosis/Thrombus

  MAUDE report 22808669 ↗
• MalfunctionApr 8, 2024Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component; Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR AN UNKNOWN ETIOLOGY USING 8 MM X 5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) IN AN UNKNOWN ANATOMICAL LOCATION. IT WAS REPORTED THE TIP OF THE DELIVERY SYSTEM CATHETER CAME OFF AS IT WAS BEING WITHDRAWN FROM THE PATIENT. THE BROKEN PIECE WAS ACCOUNTED FOR. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19063303 ↗
• MalfunctionOct 22, 2019Material Separation; Material Separation

  ON (B)(6) 2019, THE PATIENT WAS IMPLANTED WITH GORE® VIABAHN® ENDOPROSTHESES. IT WAS REPORTED THE PHYSICIAN HAD DUAL ACCESS WITH TWO 12FR DRYSEAL SHEATHS ON THE PATIENTS LEFT SIDE. IT WAS REPORTED THE GORE® VIABAHN® ENDOPROSTHESES WERE IMPLANTED IN THE PATIENT¿S LEFT COMMON ILIAC ARTERY USING A KISSING TECHNIQUE. ONE (11X5) VIABAHN DEVICE WAS IMPLANTED RETROGRADE FROM THE GROIN. THIS DEVICE EXTENDED INTO THE EXTERNAL ILIAC. A SECOND (8X10) VIABAHN DEVICE WAS IMPLANTED ANTEGRADE FROM THE AXILLARY. THIS DEVICE REPORTEDLY EXTENDED INTO THE INTERNAL ILIAC. THE PHYSICIAN THEN PLACED A (9X15) VIABAHN DEVICE THROUGH THE (8X10) VIABAHN DEVICE EXTENDING FURTHER INTO THE INTERNAL ARTERY. IT WAS REPORTED DURING EXTENSION OF THE (8X10) VIABAHN DEVICE INTO THE COMMON ILIAC ARTERY A (8X5) VIABAHN DEVICE WAS ADVANCED FROM THE AXILLARY SHEATH WITHOUT ISSUE INTO THE (8X10) VIABAHN DEVICE IN THE COMMON ILIAC. THE PHYSICIAN DEPLOYED THE STENT FULLY. IT WAS REPORTED THE DEPLOYMENT LINE BROKE AT THE HUB OF THE CATHETER. THE CATHETER WAS THEN REMOVED WITHOUT INCIDENT. THERE WAS REPORTEDLY NO ADVERSE EVENTS TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9218950 ↗