GORE VIABAHN Endoprosthesis VBCR081001ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132623525), received between Jan 30, 2019 and Feb 23, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2026Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2026, A PATIENT UNDERWENT A REVISION OF A NATIVE FISTULA PROCEDURE FOR VASCULAR ACCESS IN THE UPPER RIGHT ARM, DURING WHICH A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS USED. DURING THE PROCEDURE, THE DELIVERY CATHETER WAS ADVANCED WITHOUT RESISTANCE THROUGH AN MERIT 8F SHEATH OVER A COOK BENTSON GUIDEWIRE TO THE TARGET TREATMENT SITE. THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE; HOWEVER, THE DEVICE DID NOT DEPLOY AS INTENDED. THE REPORTER STATED THAT WHEN PULLING ON THE DEPLOYMENT LINE, RESISTANCE WAS FELT. THE PHYSICIAN PULLED HARDER AND EXPERIENCED MORE RESISTANCE THAN DESIRED AND SUBSEQUENTLY DECIDED TO WITHDRAW THE DELIVERY CATHETER. A NEW VIABAHN DEVICE OF THE SAME SIZE WAS USED, AND THE REPLACEMENT DEVICE DEPLOYED AS INTENDED. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415700 ↗
• InjuryDec 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A DIALYSIS ACCESS GRAFT REVISION (NON-GORE GRAFT). REPORTEDLY AFTER THE DEVICE WAS SUCCESSFULLY DELIVERED, THE PHYSICIAN FELT RESISTANCE DURING THE REMOVAL OF THE DELIVERY CATHETER. AFTER THE REMOVAL OF THE DELIVERY CATHETER, IT WAS OBSERVED TO BE MISSING THE DISTAL PORTION OF THE DELIVERY CATHETER. THE PATIENT WAS SENT HOME AND ADVISED TO GO TO THE EMERGENCY ROOM (ER) THE NEXT DAY. THE PATIENT WENT TO THE ER AND HAD THE CATHETER PIECE REMOVED WITH A SNARE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 23706915 ↗
• MalfunctionSep 3, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6), 2025 A PATIENT UNDERWENT A PROCEDURE FOR STENOSIS IN A PREVIOUSLY IMPLANTED UPPER EXTREMITY GRAFT (BRAND UNKNOWN) USING AN 8 MM × 10 CM GORE® VIABAHN® ENDOPROSTHESIS. IT WAS REPORTED VASCULAR ACCESS WAS ESTABLISHED USING AN UNKNOWN SIZE / BRAND INTRODUCER SHEATH OVER A AN UNKNOW SIZE / BRAND GUIDE WIRE. IT IS UNKNOWN WHETHER THE TARGET LESION UNDERWENT PRE-DILATION PRIOR TO ATTEMPTED DEVICE DELIVERY. REPORTEDLY, DURING DEPLOYMENT THE DEPLOYMENT LINE WAS PULLED AND THE ENDOPROSTHESIS STARTED BUCKLING. THE DELIVERY SYSTEM CATHETER WAS WITHDRAWN FROM THE PATIENT INTACT AND WITHOUT DISTAL EXPANSION OF THE ENDOPROSTHESIS. THE DEPLOYMENT LINE APPEARED TO BE WRAPPED AROUND THE END OF THE STENT. REPORTEDLY, THE DEPLOYMENT LINE WAS NOT BROKEN. AN ATTEMPT TO ACTUATE THE DEPLOYMENT MECHANISM OUTSIDE THE PATIENT WAS MADE. THE ENDOPROSTHESIS DEPLOYED ON THE BACK TABLE WITH EXTRA FORCE. NO IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956616 ↗
• MalfunctionSep 13, 2024Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT A TREATMENT OF AN AV FISTULA IN THE UPPER LEFT ARM WHERE A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS INTENDED TO BE IMPLANTED. IT WAS REPORTED THE PHYSICIAN WAS ABLE TO REACH THE TARGET TREATMENT AREA WITH NO RESISTANCE USING AN UNKNOWN SHEATH AND A .035" GUIDEWIRE (UNKNOWN BRAND). THE PHYSICIAN INITIATED DEPLOYMENT BY PULLING THE DEPLOYMENT LINE ALL THE WAY, HOWEVER, THE VIABAHN DEVICE FAILED TO DEPLOY. THE DEPLOYMENT LINE WAS PULLED AND REMOVED ALL THE WAY OUT OF THE PATIENT AND THE VIABAHN DEVICE REMAINED CONSTRAINED ON THE DELIVERY CATHETER. THERE WAS NO DEVICE EXPANSION OBSERVED NOR DEPLOYMENT LINE BREAKAGE. THE VIABAHN DEVICE WAS REMOVED FROM THE PATIENT THROUGH THE SHEATH AND THE PROCEDURE WAS COMPLETED USING A NEW VIABAHN DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20214454 ↗
• MalfunctionApr 4, 2024Device Slipped; Activation Problem; Device Slipped; Activation Problem

  THE FOLLOWING WAS REPORTED TO GORE: DURING A PROCEDURE FOR AN AVG FISTULA IN THE LEFT UPPER ARM, THE BRACHIAL TO BASILIC VEIN WAS TREATED. AN 8FR MERIT SHEATH, 180 BENSON WIRE (BOSTON SCIENTIFIC) WERE USED TO ADVANCE THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE). AS REPORTED, THERE WAS SOME DIFFICULTY DURING DEPLOYMENT. WHEN THE DEPLOYMENT LINE WAS PULLED SOME BUCKLING OR BOW STRINGING WAS OBSERVED AT THE CATHETER DISTAL TIP. THE VIABAHN DEVICE WAS FULLY EXPANDED, BUT DEVICE LANDED SLIGHTLY OUT OF THE TARGET TREATMENT SITE. A SECOND VIABAHN DEVICE WAS ADVANCED AND DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19047426 ↗
• MalfunctionJul 10, 2023Activation Failure; Activation Failure

  ON (B)(6) 2023, A PATIENT UNDERWENT TREATMENT IN THE ARM FOR DIALYSIS ACCESS STENOSIS UTILIZING AN 8 MM X 10 CM GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE). IT WAS REPORTED THE PHYSICIAN ADVANCED THE DELIVERY SYSTEM CATHETER THROUGH THE SHEATH AND OVER THE GUIDEWIRE (BRAND AND SIZES UNKNOWN) WITHOUT RESISTANCE. REPORTEDLY, RESISTANCE WAS FELT WHEN THE DEPLOYMENT STRING WAS PULLED. DURING THE ATTEMPTED DEPLOYMENT, THE DEVICE EXPANDED 2 CENTIMETER AND THEN THE LINE BROKE. THE DEVICE WAS REMOVED FROM THE PATIENT INTACT. THE PROCEDURE WAS COMPLETED WITH ANOTHER VIABAHN DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17290618 ↗
• InjuryJul 8, 2019Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT PRESENTED FOR A-V OUTFLOW TREATMENT OF TWO STENOTIC AREAS IN THE AXILLARY VEIN. AN 8FR SHEATH WAS USED TO ADVANCE THE GORE® VIABAHN® ENDOPROSTHESIS. THE FIRST STENOTIC SECTION WAS CROSSED AND DILATED WITH NO ISSUES. A VIABAHN DEVICE (8 X 10) WAS DEPLOYED WITH NO ISSUES. THE SECOND SECTION WAS EXTREMELY FOCAL STENOSIS THAT DID NOT YIELD TO DILATION. HOWEVER, THE PHYSICIAN WAS ABLE TO ADVANCE THE SECOND VIABAHN DEVICE (8 X 5) THROUGH THE NARROWING IN THE AXILLARY VEIN. THE VIABAHN DEVICE WAS DEPLOYED AND IT CONFORMED TO THE VESSEL WALL. AFTER DEVICE WAS DEPLOYED, THE DELIVERY CATHETER COULD NOT BE WITHDRAWN AS IT WAS STUCK INSIDE THE DEPLOYED DEVICE. THE PATIENT WAS TRANSFERRED TO A HOSPITAL. THE DEPLOYED VIABAHN DEVICE AND CATHETER WERE SURGICALLY REMOVED FROM THE PATIENT. THE STENOSIS WAS THEN TREATED AND THE PATIENT'S VESSEL WAS PATCHED. THE PATIENT WAS REPORTED TO BE RECOVERING WELL FOLLOWING THE PROCEDURE.

  Patient problems: Perforation

  MAUDE report 8769738 ↗
• InjuryJul 1, 2019Partial Blockage; Failure to Unfold or Unwrap; Detachment of Device or Device Component; Partial Blockage; Failure to Unfold or Unwrap; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: DURING DEPLOYMENT OF THE GORE® VIABAHN® ENDOPROSTHESIS, RESISTANCE WAS MET PULLING BACK THE DEPLOYMENT LINE. THE TECH STOPPED IMMEDIATELY AND INFORMED THE DOCTOR. THE DOCTOR ATTEMPTED TO CONTINUE DEPLOYMENT BUT WAS UNABLE. AFTER MULTIPLE ATTEMPTS TO DEPLOY THE STENT, THE DOCTOR PULLED THE CATHETER OUT, LEAVING BEHIND A PARTIALLY DEPLOYED GORE® VIABAHN® ENDOPROSTHESIS. THE PATIENT WAS SENT TO CHRISTIANA HOSPITAL FOR EMERGENT DIALYSIS CATHETER INSERTION AND SURGERY TO REMOVE THE GORE® VIABAHN® ENDOPROSTHESIS.

  Patient problems: Stenosis

  MAUDE report 8749480 ↗
• InjuryJun 11, 2019Break; Activation, Positioning or Separation Problem; Material Deformation; Physical Resistance/Sticking

  VIABAHN STENT-GRAFT BEING USED TO TREAT STENOSIS OF AV GRAFT OUTFLOW VEIN. THE STENT-GRAFT WAS SITUATED PERFECTLY IN A STRAIGHT VANE SEGMENT, OVER A 0.038" BENTSON GUIDEWIRE, WHICH IS OUR STANDARD FOR THIS PROCEDURE. DURING ATTEMPTED DEPLOYMENT, AFTER APPROXIMATELY 2/3 OF THE STENT HAVE BEEN EXPANDED, DEPLOYMENT DASHBOARD IS SUDDENLY STRUCK AND COULD NOT BE PULLED ANY FURTHER. MULTIPLE ATTEMPTS TO GET THE COURT TO RELEASE THE REMAINING UNOPENED STENT-GRAFT WERE UNSUCCESSFUL. THE WIRE WAS REPLACED WITH A SUPER-STIFF AMPLATZ WIRE, WHICH DID NOT SUBSTANTIALLY CHANGE THE CONFIGURATION OF THE STENT-GRAFT; THE CORD WOULD STILL NOT RELEASE THE STENT-GRAFT. THERE WAS MARKED DEFORMATION AND SEGMENTAL PARTICLE EXPANSION OF THE STENT-GRAPH. FINALLY, WITH INTENTIONALLY EXCESSIVE FORCE, THE [INVALID] SNAPPED, AND THE STENT WAS LEFT COMPLETELY OPENED, RESULTING IN OBSTRUCTION OF THE TARGET VESSEL. ATTEMPTS TO EXTRACT THE STENT USING A SNARE WERE UNSUCCESSFUL. THE GRAFT HAD TO BE OCCLUDED TO AVOID EXTRAVASATION AROUND THE MAL-DEPLOYED SENT. THE PATIENT WAS SENT BY AMBULANCE TO HOSPITAL, ADMITTED FOR A MANAGEMENT OF THIS COMPLICATION, OBSERVATION, AND SURGICAL GRAFT SALVAGE. HE NEEDED ACUTE FEMORA

  Patient problems: Obstruction/Occlusion

  MAUDE report 8692458 ↗
• MalfunctionJan 30, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: THE DOCTOR, USING PERCUTANEOUS ACCESS DURING AN AV CASE, ADVANCED THE GORE® VIABAHN® ENDOPROSTHESIS THROUGH THE WALL OF A VASCULAR GRAFT WITHOUT A SHEATH. THE DEVICE WAS ADVANCED TO THE TARGET AREA AND DEPLOYED AS EXPECTED. WHEN THE CATHETER WAS WITHDRAWN FROM THE PATIENT IT WAS OBSERVED THAT APPROXIMATELY 10CM OF THE DISTAL END OF THE CATHETER WAS MISSING. UNDER FLUOROSCOPY THE DOCTOR OBSERVED THE END STILL ON THE WIRE INSIDE THE PATIENT AND WAS ABLE TO SNAG THE BROKEN PIECE FROM THE PATIENT. THE GORE® VIABAHN® ENDOPROSTHESIS WAS REPORTED BY THE DOCTOR TO BE FUNCTIONING AS INTENDED AT THE CONCLUSION OF THE PROCEDURE. THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: Fistula

  MAUDE report 8290727 ↗