GORE VIABAHN Endoprosthesis with Heparin VBHR091502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132646005), received between Sep 18, 2020 and Dec 19, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Failure” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AN ANEURYSM IN THE POPLITEAL ARTERY, UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. REPORTEDLY, THE DELIVERY SYSTEM CATHETER ADVANCED THROUGH A 10F SHEATH (BRAND UNKNOWN) OVER A .035" GLIDE ADVANTAGE GUIDEWIRE TO THE TARGET TREATMENT SITE. THE DELIVERY CATHETER SUCCESSFULLY REACHED THE INTENDED TREATMENT SITE. DURING DEPLOYMENT, THE DEPLOYMENT LINE WAS REPORTEDLY PULLED, AND THE DEPLOYMENT LINE APPEARED TO UNZIP FROM THE HUB UP TO THE TIP BUT THEN STOPPED. THERE WAS NO DISTAL EXPANSION OF THE ENDOPROSTHESIS INITIATED. THE PHYSICIAN WAS UNSURE OF THE CAUSE OF THE DEPLOYMENT FAILURE. THE DELIVERY CATHETER WAS PULLED BACK INTO THE INTRODUCER SHEATH AND WAS WITHDRAWN FROM THE PATIENT INTACT. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856796 ↗
• InjurySep 18, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2020, A GORE® VIABAHN® ENDOPROSTHESIS (VSX) WAS BEING PLACED AS A FENESTRATION DEVICE, IN THE MESENTERIC ARTERY. THE ACCESS WAS GAINED FROM THE ARM INTO THE SUBCLAVIAN ARTERY USING A 8.8FR COOK INTRODUCER SHEATH. AFTER THE PHYSICIAN ACCESSED THE MESENTERIC ARTERY, HE USED A TECHNIQUE OF RETRACTING THE SHEATH WHILE DEPLOYING THE DEVICE. WHEN HE THOUGHT THE DEVICE WAS FULLY DEPLOYED, HE ATTEMPTED TO REMOVE THE DEVICE CATHETER AND FELT SOME RESISTANCE. UNDER FLUOROSCOPY IT WAS NOTICED THAT THE DEVICE HAD BEEN PULLED BACK INTO THE AORTA. THE PHYSICIAN RETRACTED THE DEVICE TO THE INTRODUCER SHEATH AND ATTEMPTED TO REMOVE THE DEVICE AND SHEATH IN TANDEM. HOWEVER, WHEN THE DEVICE WAS BEING REMOVED IT HAD BECOME DEPLOYED IN THE SUBCLAVIAN ARCH. THE PHYSICIAN THAN HAD TO PERFORM A CUT DOWN PROCEDURE TO REMOVE THE DEVICE. AN ADDITIONAL VSX DEVICE WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10554343 ↗