GORE VIABAHN Endoprosthesis with Heparin VBHR081002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00733132623136), received between May 29, 2019 and May 21, 2026 — classified as 1 injury, 4 malfunctions.

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

• InjuryMay 21, 2026Entrapment of Device; Detachment of Device or Device Component; Device Damaged by Another Device; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, TREATMENT WAS REQUIRED IN THE PATIENT'S ILIAC ARTERY DUE TO AN ANEURYSM. AS REPORTED, A PREVIOUSLY IMPLANTED BARE METAL STENT WAS AT THE INTENDED TREATMENT SITE. THROUGH A SHEATH (UNSPECIFIED BRAND/SIZE) A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS ADVANCED OVER A LUNDERQUIST WIRE. IT WAS REPORTED THE PHYSICIAN DID NOT REALIZE THE WIRE WENT INTO INTERSTICES OF EXISTING BARE METAL STENT. THE VIABAHN® DEVICE DEPLOYMENT WAS STARTED AND THE FIRST LAYER UNRAVELED, THEN THE DEPLOYMENT LINE BROKE ON THE BARE METAL STENT. AS REPORTED, THE VIABAHN® STENT PARTIALLY EXPANDED; THE CATHETER WAS STUCK AND THE PHYSICIAN ATTEMPTED TO PULL BACK THE VIABAHN® CATHETER. THE DISTAL TIP BROKE OFF WHEN PULLING THE WIRE THAT WAS STUCK IN THE CATHETER. A CUTDOWN WAS PERFORMED TO REMOVE THE VIABAHN® DEVICE. IT WAS REPORTED THE PATIENT IS RECOVERING WELL.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 25250079 ↗
• MalfunctionOct 17, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: A DIALYSIS PATIENT WAS TREATED DUE TO A STENOSED VASCULAR GRAFT (UNKNOWN MANUFACTURER) THAT WAS IMPLANTED IN THE LEFT ARM ON AN UNKNOWN DATE. AN 0.035 STIFF GLIDE WIRE AND AN 8 X 11 BRITE TIP SHEATH WERE USED TO ADVANCE THE 8 X 10 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE). AS REPORTED, THE DEPLOYMENT KNOB WAS UNSCREWED AND DEPLOYMENT LINE WAS PULLED; HOWEVER, SIGNIFICANT RESISTANCE WAS FELT. THE PHYSICIAN ALSO REPORTED THERE WAS NOT ENOUGH SUPPORT FOR THE DELIVERY CATHETER AT THE ENTRY POINT INTO THE SHEATH TO DEPLOY THE VIABAHN® DEVICE. THE CONSTRAINED VIABAHN® DEVICE WAS REMOVED FROM THE SHEATH WITH NO ISSUES. A NON-GORE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23329973 ↗
• MalfunctionSep 13, 2021Separation Failure; Separation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021 A PATIENT PRESENTED WITH AN UNKNOWN ETIOLOGY AT AN UNKNOWN ANATOMICAL LOCATION AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE DEVICE. THE VIABAHN DEVICE WAS ABLE TO BE SUCCESSFULLY DEPLOYED (UTILIZING AN 8FR CORDIS BRITE TIP® SHEATH), BUT THE DEPLOYMENT STRING DIDN'T COMPLETELY DETACH AND INSTEAD REMAINED IN THE PATIENT. THE PHYSICIAN WAS ABLE TO SNARE THE DEPLOYMENT STRING AND REMOVE IT FROM THE PATIENT ENTIRELY. PATIENT TOLERATED THE PROCEDURE. IT WAS ALSO REPORTED THAT THIS WAS A VENOUS APPLICATION, BUT NO FURTHER INFORMATION ON EXACT LOCATION/DISEASE STATE IS KNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12459541 ↗
• MalfunctionAug 28, 2020Premature Activation; Premature Activation

  ON (B)(6) 2020, A PATIENT WAS BEING TREATED IN AN EMERGENT CASE DUE TO A RIGHT-SIDE RETROPERITONEAL BLEEDING. AS REPORTED, THE PATIENT'S VESSELS WERE HEAVILY CALCIFIED. USING A SHORT 8FR SHEATH (UNKNOWN BRAND), A GORE® 8MM X 10CM VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS ADVANCED OVER A WIRE FROM THE CONTRALATERAL SIDE TO TREAT THE RIGHT EXTERNAL ILIAC ARTERY. HOWEVER, THE SHEATH AND VIABAHN DEVICE GOT CAUGHT ON THE CALCIFICATION. AT THIS TIME, THE VIABAHN DEVICE UNEXPECTEDLY 'SELF-DEPLOYED' IN THE LEFT EXTERNAL ILIAC ARTERY. A BALLOON WAS INSERTED AND AN ANGIOPLASTY WAS PERFORMED WITHIN THE VIABAHN DEVICE. THE SHORT 8FR SHEATH WAS THEN EXCHANGED FOR A LONG 8FR SHEATH. A SECOND VIABAHN DEVICE (8MM X 10CM) WAS ADVANCED OVER THE WIRE INTO THE RIGHT EXTERNAL ILIAC ARTERY. IT WAS DEPLOYED UNDER FLUOROSCOPY WITH NO ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10466157 ↗
• MalfunctionMay 29, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF AN AV ACCESS VESSEL STENOSIS IN THE THIGH WITH A GORE® VIABAHN® ENDOPROSTHESIS. NO ADVERSE OUTCOMES WERE REPORTED AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2019 A BALLOON ANGIOPLASTY WAS PERFORMED IN A NON-TREATED SEGMENT OF THE VESSEL. WHEN THE BALLOON CATHETER WAS BEING REMOVED FROM THE VESSEL, THROUGH THE PREVIOUSLY IMPLANTED VIABAHN, SOME RESISTANCE WAS NOTED. THE BALLOON CATHETER AND SHEATH WERE REMOVED TOGETHER. AN OLIVE TIP WITH A SMALL SEGMENT (APPROXIMATELY 10 MM) OF A DELIVERY CATHETER CAME OUT ALONG WITH THE BALLOON CATHETER AND SHEATH. THERE WAS NO ADVERSE OUTCOME FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8652148 ↗