GORE VIABAHN Endoprosthesis with Heparin VBHR081501ARecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00733132623143), received between Feb 2, 2026 and Aug 4, 2026 — classified as 1 injury, 2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2026Insufficient Device Problem Information

  On (b)(6) 2026, the patient underwent treatment for an aneurysm within a pre-existing AV fistula using two GORE® VIABAHN® Endoprosthesis with HEPARIN Bioactive Surface (VIABAHN Devices) that were intended to be placed in the arm. It was reported the physician advanced the VIABAHN Devices through an 8F TERUMO Sheath over a .035" GLIDEWIRE Guidewire. It was reported both VIABAHN Devices prematurely dislodged from the delivery catheters after insertion. It is unknown if there was any resistance during advancement. It is also unknown if there was an attempt to deploy the VIABAHN Devices and it is unknown what condition the deployment lines were in. It was reported, both VIABAHN Devices were removed from the patient. To complete the procedure, it was reported the AV fistula needed surgical conversion for repair.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50132714 ↗
• MalfunctionMay 21, 2026Activation Failure

  ON (B)(6) 2026, THE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE TO TREAT A STENOSED STENT (UNKNOWN MANUFACTURE) WITHIN AN ARTERIOVENOUS (AV) FISTULA IN THE ARM USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE). DURING THE PROCEDURE, THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING THE VIABAHN DEVICE TO THE TARGET TREATMENT AREA USING AN UNSPECIFIED SHEATH AND GUIDEWIRE. HOWEVER, UPON INITIATION OF DEPLOYMENT, THE PHYSICIAN NOTED THAT THE DEPLOYMENT LINE WOULD NOT PULL, RESULTING IN FAILURE TO DEPLOY. NO PORTION OF THE DEPLOYMENT LINE WAS SUCCESSFULLY PULLED, AND NO DEVICE EXPANSION WAS OBSERVED. DUE TO THE INABILITY TO DEPLOY THE VIABAHN DEVICE, THE PHYSICIAN WITHDREW THE VIABAHN DEVICE THROUGH THE SHEATH AND DISCARDED IT. A NEW VIABAHN DEVICE WAS SUBSEQUENTLY INTRODUCED AND DEPLOYED SUCCESSFULLY WITHOUT ISSUE, COMPLETING THE PROCEDURE. THE PHYSICIAN REPORTED THAT NO FORCE WAS USED TO PULL THE DEPLOYMENT LINE AND WAS UNSURE OF THE EXACT CAUSE OF THE ISSUE BUT SUSPECTED THAT THE DEPLOYMENT LINE MAY HAVE BECOME CAUGHT ON THE PREVIOUSLY IMPLANTED STENT WITHIN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25245070 ↗
• MalfunctionFeb 2, 2026Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2026, THE PHYSICIAN PERFORMED A DECLOT IN THE PATIENT'S LEFT BRACHIAL VEIN. IT WAS REPORTED THERE WERE NO PRE-EXISTING DEVICES IN THE AREA OF TREATMENT. A CUT DOWN WAS PERFORMED AND THROMBECTOMY WITH A FOGARTY BALLOON WAS DONE. THEN A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) WAS PERFORMED USING AN 8 X 40 CONQUEST BALLOON. IT WAS REPORTED THERE WAS RESIDUAL STENOSIS. PRIOR TO IMPLANT OF A DEVICE, THE ENTIRE AREA WAS PRE-DILATED WITH AN 8 MM BALLOON AND NO RESISTANCE WAS FELT WHILE DELIVERING THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE). FOR THE REMAINING STENOSIS, AN 8MM X 15CM VIABAHN® DEVICE WAS TO BE IMPLANTED. AS THERE WAS A CUT-DOWN, IT WAS REPORTED A SHEATH WAS NOT USED. THE VIABAHN® DEVICE WAS ADVANCED OVER AN .035 STIFF ANGLED GLIDE WIRE. WHEN THE DEPLOYMENT LINE WAS PULLED, A SHORT SEGMENT OF THE LINE UNRAVELED, BUT GOT STUCK AND FURTHER DEPLOYMENT WAS NOT POSSIBLE. UNDER X-RAY, IT WAS CONFIRMED THE DEPLOYMENT LINE WAS NOT HUNG UP ON ANYTHING AND THERE WAS NO DEVICE EXPANSION. THE CONSTRAINED VIABAHN® DEVICE WAS REMOVED. A NEW VIABAHN® DEVICE WAS DELIVERED OVER THE SAME .035 STIFF ANGLED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24236009 ↗