GORE VIABAHN Endoprosthesis with Heparin VBJR081502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00733132623839), received between Jul 25, 2019 and Sep 28, 2026 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50925884 ↗
• MalfunctionSep 4, 2026Activation Failure; Physical Resistance/Sticking

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50623722 ↗
• MalfunctionFeb 9, 2026Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2026, A MALE PATIENT UNDERWENT AN ENDOVASCULAR STENTING PROCEDURE TO TREAT ANEURYSM AND OCCLUSION OF THE POPLITEAL ARTERY DURING WHICH A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS USED. DURING THE PROCEDURE, THE DEVICE EXPERIENCED DIFFICULTY DURING DEPLOYMENT. THE DEPLOYMENT LINE WAS DIFFICULT TO PULL, AND BOWSTRINGING WAS OBSERVED. DEPLOYMENT WAS STOPPED. NO DISTAL EXPANSION WAS INITIATED, AND THE DEVICE WAS WITHDRAWN BACK THROUGH THE SHEATH. THE REPORTER STATED THAT THE GUIDEWIRE (UNKNOWN BRAND) DID NOT PROVIDE SUFFICIENT SUPPORT (NOT STIFF ENOUGH), AND THE UP-AND-OVER APPROACH FROM GROIN ACCESS CREATED A LONG DEVICE PATH, WHICH COULD HAVE CONTRIBUTED TO THE DEPLOYMENT FAILURE. THE PROCEDURE WAS COMPLETED USING ANOTHER VIABAHN DEVICE. NO ADDITIONAL PROCEDURAL OR CLINICAL DETAILS WERE PROVIDED, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292348 ↗
• MalfunctionSep 3, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6), 2025, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE BRACHIOCEPHALIC ARCH DURING TREATMENT OF FISTULA. AFTER THE VSX DEVICE WAS ADVANCED ACROSS THE LESION, THE PHYSICIAN ATTEMPTED TO DEPLOY. HOWEVER, DURING DEPLOYMENT THE DEPLOYMENT LINE WAS STUCK AT THE TURN AROUND STARTED TO BOW STRING. THE PHYSICIAN REMOVED THE DEVICE AND SUCCESSFULLY COMPLETED THE PROCEDURE WITH A NEW VSX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22956094 ↗
• MalfunctionMay 16, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, A PATIENT HAD A PROCEDURE FOR AN UNKNOWN ETIOLOGY WHERE AN 8 MM X 15 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (GORE® VIABAHN® DEVICE) WAS INTENDED TO BE USED IN AN UNKNOWN ANATOMICAL LOCATION. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT USING AN 8F COOK INTRODUCER SHEATH OVER AN .018" V-18 STIFF GUIDEWIRE. REPORTEDLY, DURING DEPLOYMENT, THE DEPLOYMENT LINE WAS PULLED AND THERE WAS RESISTANCE. THE DEVICE WAS NOT DEPLOYING EASILY AND REQUIRED TOO MUCH FORCE TO DEPLOY. THEREFORE, THE DECISION TO STOP DEPLOYMENT WAS MADE. THE DELIVERY CATHETER WITH THE CONSTRAINED ENDOPROSTHESIS WAS WITHDRAWN FROM THE PATIENT AND WAS DEPLOYED WITH DIFFICULTY / RESISTANCE ON THE BACK TABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER GORE® VIABAHN® DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22039979 ↗
• MalfunctionOct 28, 2024Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON OCTOBER 17, 2024, A 8 MM X 15 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS INTENDED FOR USE IN AN OFF LABEL PROCEDURE TO TREAT FEMORAL-POPLITEAL ANEURYSMS AND WAS IMPLANTED IN THE VEIN EXTENDING OFF OF A FEM-POP BYPASS. REPORTEDLY, THE VIABAHN® DEVICE WAS ADVANCED OVER A BOSTON SCIENTIFIC V-18 GUIDEWIRE THROUGH A 7 F TERUMO DESTINATION INTRODUCER SHEATH. IT WAS NOTED WHEN THE PHYSICIAN PULLED THE DEPLOYMENT LINE OF THE VIABAHN® DEVICE IT WAS STUCK, AND THEREFORE LED TO FAILURE TO DEPLOY VIABAHN® DEVICE. THE PHYSICIAN THEN REMOVED THE VIABAHN® DEVICE WITHOUT DIFFICULTY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER 8 MM X 15 CM VIABAHN® DEVICE. THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20553355 ↗
• MalfunctionJun 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE DURING TREATMENT OF DIALYSIS OUTFLOW STENOSIS. IT WAS REPORTED DURING THE ADVANCEMENT OF THE VSX DEVICE THROUGH THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN) THE DEVICE HAD BECOME STUCK. DURING THE ATTEMPTED REMOVAL OF THE VSX DEVICE FROM THE INTRODUCER SHEATH THE DELIVERY CATHETER BROKE. THE PHYSICIAN USED A SNARE TO REMOVE THE VSX AND BROKEN DELIVERY CATHETER FROM THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED WITH AN ADDITIONAL VSX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19563837 ↗
• MalfunctionMar 7, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, THE PATIENT UNDERWENT TREATMENT FOR A THORACIC ANEURYSM USING AN AORTIC DEVICE AND A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) IN THE SUPERIOR MESENTERIC ARTERY (SMA) VIA SNORKELING TECHNIQUE. IT WAS REPORTED THE PHYSICIAN ADVANCED THE DELIVERY CATHETER THROUGH SOME MILD CALCIFICATION TO THE TARGET TREATMENT SITE USING A 7F COOK INTRODUCER SHEATH OVER A SV-5 GUIDEWIRE. THE DEPLOYMENT LINE WAS PULLED AND BECAME STUCK. THE PHYSICIAN WAS ABLE TO PULL OUT 4 INCHES OF THE DEPLOYMENT LINE BEFORE IT BECAME STUCK. REPORTEDLY, THERE WAS NO DISTAL EXPANSION OF THE ENDOPROSTHESIS. THE PHYSICIAN RE-ADVANCED THE SHEATH OVER THE ENDOPROSTHESIS, AND WITHDREW THE DELIVERY CATHETER THROUGH THE SHEATH WITHOUT ANY ISSUES. THE PROCEDURE WAS COMPLETED USING ANOTHER 8 MM X 15 CM VIABAHN® DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18857355 ↗
• MalfunctionAug 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: DURING A POPLITEAL ANEURYSM ENDOVASCULAR PROCEDURE, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (DEVICE) WAS ADVANCED THROUGH A COOK 7FR SHEATH OVER A .018 STEELCORE WIRE. THE DEVICE WAS DELIVERED TO THE TARGET TREATMENT AND DEPLOYMENT WAS INITIATED. AS DEVICE STARTED TO EXPAND AT THE DISTAL END, THE PATIENT SUDDENLY MOVED, CAUSING THE DEVICE TO LOSE PURCHASE IN THE ANEURYSM. THE SLIGHTLY EXPANDED DEVICE WAS ABLE TO BE PULLED BACK INTO THE SHEATH AND WAS REMOVED FROM THE PATIENT WITH NO ISSUES. THE PROCEDURE ENDED WITH NO DEVICE PLACEMENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. AS REPORTED, PHYSICIAN STATED THERE WERE NO ISSUES WITH THE DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362152 ↗
• InjuryDec 5, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT WAS TREATED FOR STENOTIC OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY USING TWO GORE® VIABAHN® ENDOPROSTHESES. IT WAS REPORTED BOTH DEVICES WERE DELIVERED IN THEIR INTENDED LOCATION WITHOUT ISSUE. ON THE SAME DATE, POST OPERATION, OCCLUSION OF THE DEVICES WAS IDENTIFIED. THE PHYSICIAN STATED THE SUSPECTED CAUSE OF THE OCCLUSIONS IS UNKNOWN. A REINTERVENTION WAS PERFORMED TO TREAT THE STENOSIS. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Occlusion

  MAUDE report 10950545 ↗
• MalfunctionJan 28, 2020Activation Problem; Activation Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2020 THE PATIENT PRESENTED WITH THROMBOSIS IN THE BRACHIAL ARTERY. AN 8MM X 15CM GORE® VIABAHN® ENDOPROSTHESIS WAS TO BE DEPLOYED AS A BRACHIAL ARTERY TO BRACHIAL VEIN FISTULA. HOWEVER, DURING DEPLOYMENT, THE DEVICE STARTED TO "BOWSTRING" AND WOULD NOT DEPLOY AFTER APPROXIMATELY 1CM OF THE DEVICE WAS EXPANDED. THE DEVICE WAS REMOVED AND AN 8MM X 15CM GORE® VIABAHN® ENDOPROSTHESIS WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE AND IS DOING WELL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9638401 ↗
• InjuryJul 25, 2019Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2019 A PATIENT WAS UNDERGOING TREATMENT OF A POPLITEAL ANEURYSM WITH A GORE® VIABAHN® ENDOPROSTHESIS. ACCESS WAS OBTAINED VIA THE CONTRALATERAL FEMORAL ARTERY, IN AN UP AND OVER APPROACH, WITH A SHORT 7FR SHEATH OVER A .014" 300CM SPARTACUS WIRE. THE DEVICE WAS ADVANCED TO THE TARGET LOCATION. WHEN DEPLOYMENT WAS ATTEMPTED THE ENDOPROSTHESIS CURLED UP LIKE A SNAKE AND THE DEPLOYMENT LINE WAS WRAPPED AROUND THE DEVICE, TERMINATING EXPANSION. THE DEVICE HAD OPENED APPROXIMATELY 1-2CM. THE DEVICE WAS REMOVED FROM THE VESSEL WITHOUT APPARENT DAMAGE, HOWEVER THE PROCEDURE WAS CONVERTED TO OPEN BYPASS. THE PATIENT DID WELL FOLLOWING THE BYPASS PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8829358 ↗