GORE VIABAHN Endoprosthesis with Heparin VBHR060502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132622764), received between Mar 4, 2022 and Oct 25, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionOct 25, 2024Break; Break

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED OR FOR USE TO TREAT A POPLITEAL ANEURYSM. REPORTEDLY, THE VIABAHN DEVICE WAS ADVANCED OVER A 0.035" ROSENWIRE THROUGH AN UNKNOWN SIZE AND BRAND INTRODUCER SHEATH. IT WAS NOTED WHEN THE DEPLOYMENT LINE WAS PULLED IT BROKE AND THE VIABAHN DEVICE FAILED TO DEPLOY. THE VIABAHN DEVICE WAS REMOVED WITHOUT DIFFICULTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER VIABAHN DEVICE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20537964 ↗
• MalfunctionApr 15, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2024, A PATIENT UNDERWENT A PHYSICIAN-MODIFIED ENDOVASCULAR GRAFT (PMEG) PROCEDURE FOR AN ANEURYSM WHERE A 5 MM X 6 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS INTENDED TO BE USED IN THE LEFT RENAL ARTERY. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT VIA THE GROIN USING A 7F MEDTRONIC TOURGUIDE SHEATH OVER AN UNKNOWN GUIDEWIRE AND THROUGH A FENESTRATION ON A COOK® ZENITH FLEX® AAA ENDOVASCULAR GRAFT. REPORTEDLY, THERE WERE NO MODIFICATIONS MADE TO THE VIABAHN DEVICE OR DELIVERY SYSTEM AS PART OF THE PROCEDURE. THE DELIVERY CATHETER WAS ADVANCED BUT WOULD NOT COME OUT OF THE SHEATH INTO THE ARTERY DUE TO THE ANGLE OF THE ANATOMY AND SHEATH. THE PHYSICIAN ADJUSTED THE BEND IN THE SHEATH, BUT THE DELIVERY CATHETER STILL WOULD NOT ADVANCE. REPORTEDLY, THE PHYSICIAN DECIDED TO WITHDRAW THE DELIVERY CATHETER IN ORDER TO PREDILATE. THERE WAS A LOT OF FRICTION DURING WITHDRAWAL DUE TO THE COMPLEXITY OF THE CASE. WHEN THE DELIVERY CATHETER WAS REMOVED, A RADIOPAQUE (RO) OBJECT WAS OBSERVED ON IMAGING IN THE LEFT KIDNEY. INITIALLY THE PHYSICIAN SUSPECTED ONE OF THE THREE RO MARKER BANDS FROM A PHILLIPS QUICK-CROSS SUPPORT CATHETER (AL

  Patient problems: Foreign Body In Patient

  MAUDE report 19105673 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO GORE THAT DURING A PROCEDURE TO TREAT THE SUPERFICIAL FEMORAL ARTERY THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE GOT STUCK AND THE PROCEDURE NEEDED TO BE CONVERTED TO A CUT DOWN PROCEDURE TO REMOVE THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14607194 ↗
• MalfunctionMar 4, 2022Loss of or Failure to Bond; Break; Entrapment of Device; Material Separation; Detachment of Device or Device Component; Physical Resistance/Sticking; Separation Problem; Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component; Separation Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT WAS BEING TREATED FOR A STENOTIC LESION IN A ILIAC ARTERY USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE VESSEL WAS PRE-DILATED PRIOR TO THE ADVANCEMENT OF THE DEVICE. THE DEVICE WAS ADVANCE AND DEPLOYED IN ITS INTENDED LOCATION WITH NO REPORTED ISSUE. RESISTANCE WAS NOTED AS THE DELIVERY CATHETER WAS BEING REMOVED FROM THE PATIENT. AS THE DELIVERY CATHETER WAS REMOVED FROM THE GUIDEWIRE IT WAS NOTED THAT THE DISTAL SHAFT WAS NOT ATTACHED. THE DISTAL SHAFT WAS SEPARATED FROM THE DELIVERY CATHETER AND WAS LOCATED IN THE PATIENTS COMMON ILIAC ARTERY. THE PHYSICIANS SUSPECTED CAUSE OF THE DISTAL SHAFT SEPARATION WAS EXCESSIVE CALCIFICATION IN THE VESSEL. ANOTHER GORE DEVICE WAS IMPLANTED TO PIN THE DISTAL SHAFT TO THE VESSEL WALL. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13675883 ↗