GORE VIABAHN Endoprosthesis VBCR081501ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132623549), received between Sep 28, 2023 and May 23, 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.

• MalfunctionMay 23, 2025Detachment of Device or Device Component; Activation Failure; Detachment of Device or Device Component; Activation Failure

  ON (B)(6) 2025, A PATIENT HAD A PROCEDURE TO TREAT VENOUS OUTFLOW WHERE AN 8 MM X 15 CM GORE® VIABAHN® ENDOPROSTHESIS WAS INTENDED TO BE USED IN AN UNKNOWN ANATOMICAL LOCATION. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT USING AN 8F TERUMO INTRODUCER SHEATH OVER AN .035" GLIDEWIRE. IT IS UNKNOWN IF THE TARGET AREA WAS PRE-DILATED. REPORTEDLY, THE DELIVERY CATHETER ADVANCED TO THE TARGET TREATMENT ZONE WITHOUT INCIDENCE. DURING DEPLOYMENT, THE DEPLOYMENT LINE WAS PULLED AND BROKE. REPORTEDLY, 3-4 CENTIMETERS OF THE ENDOPROSTHESIS REMAINED CONSTRAINED AND ON THE CATHETER. THE DELIVERY CATHETER COULD NOT BE REMOVED WITH THE ENDOPROSTHESIS STILL ATTACHED. IT WAS REPORTED A BALLOON WAS ADVANCED AND INFLATED TO HIGH PRESSURE TO GET THE DEPLOYMENT LINE TO RUPTURE AND THE STENT TO EXPAND. ANOTHER ATTEMPT TO REMOVE THE DELIVERY CATHETER WAS MADE, AND IT APPEARED THE STENT STARTED TO BUCKLE. REPORTEDLY, MORE BALLOONING WAS DONE, AND THE AGGRESSIVE BALLOONING CAUSED THE STENT TO MOVE. A SECOND GORE® VIABAHN® DEVICE WAS USED TO FULLY TREAT THE TARGET AREA. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT OTHER THAN THE PROCEDURE TOOK LONGER THAN NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22081810 ↗
• InjurySep 28, 2023Patient-Device Incompatibility; Device Damaged by Another Device; Patient-Device Incompatibility; Device Damaged by Another Device

  THE FOLLOWING WAS REPORTED TO GORE: DURING A DECLOTTING PROCEDURE IN A PATIENT'S UPPER ARM, A SUBOPTIMAL VEIN WAS RUPTURED. THE TREATMENT AREA HAD BEEN PREDILATED. AS REPORTED, THE INTENTION WAS NOT TO COVER ANY PART OF THE DIALYSIS ACCESS GRAFT (UNKNOWN MANUFACTURER). IT WAS TO COVER THE DRAINING VEIN TO INCLUDE ONLY THE VEIN GRAFT ANASTOMOSIS. AN 8FR MERIT MEDICAL SHEATH WAS USED TO ADVANCE THE GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE/STENT) TO BUT WAS UNABLE TO ADVANCE BEYOND THE LESION. DECISION WAS MADE TO WITHDRAW THE VSX DEVICE TO DILATE THE LESION AGAIN. WHILE TRYING TO REMOVE THE VSX DEVICE FROM THE PATIENT THROUGH THE 8FR SHEATH, THE PROXIMAL END OF THE VSX STENT WOULD NOT ENTER THE DISTAL END OF THE SHEATH. REPEATED ATTEMPTS WERE MADE TO MANIPULATE THE VSX STENT INTO THE SHEATH. AT THIS TIME, IT WAS VISUALIZED THE PROXIMAL PORTION OF THE STENT APPEARED FLARED AND THE DEPLOYMENT LINE WAS SEPARATED. OUTSIDE THE PATIENT, THE HUB ASSEMBLY WAS CUT TO ACCOMMODATE THE REMOVAL OF THE 8FR SHEATH. AFTER THE INITIAL SHEATH WAS REMOVED, A 9FR TERUMO SHEATH WAS ADVANCED INTO PLACE. ATTEMPTS TO REMOVE THE VSX STENT THROUGH THE 9FR SHEATH WERE UNSUCCESSFUL. AS REPORTED, THE PHYSICIAN

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

  MAUDE report 17836793 ↗