GORE VIABAHN Endoprosthesis with Heparin VBHR100502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132646029), received between Jul 14, 2021 and Aug 25, 2025 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2025Break; Activation Failure; Break; Activation Failure

  ON (B)(6) 2025, A PATIENT HAD A PROCEDURE TO TREAT VENOUS OUTFLOW WHERE A 10 MM X 5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS USED IN AN UNKNOWN ANATOMICAL LOCATION IN THE UPPER ARM. IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT USING AN 8F TERUMO INTRODUCER SHEATH (4 CM) OVER AN .035" UNKNOWN BRAND GUIDE WIRE. REPORTEDLY, THE DELIVERY CATHETER ADVANCED TO THE TARGET TREATMENT ZONE. DURING DEPLOYMENT, THE DEPLOYMENT LINE WAS PULLED AND BROKE. IT IS SUSPECTED THE DEPLOYMENT LINE GOT CAUGHT ON SOMETHING CAUSING IT TO BREAK. REPORTEDLY, THE ENDOPROSTHESIS REMAINED PARTIALLY CONSTRAINED AND ON THE CATHETER. THE DECISION WAS MADE TO CUT THE DELIVERY CATHETER (OUTSIDE THE PATIENT) IN ATTEMPT TO LOCATE THE DEPLOYMENT LINE. THE DEPLOYMENT LINE WAS FOUND AND PULLED. IT WAS REPORTED THE ENDOPROSTHESIS EXPANDED, AND WAS IMPLANTED IN THE INTENDED TREATMENT LOCATION. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22884552 ↗
• MalfunctionJun 3, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A STENOSIS IN THE CEPHALIC ARCH, AN 8FR SHEATH (UNSPECIFIED BRAND) WAS USED TO ADVANCE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) OVER A .035/260 CM COOK EXCHANGE WIRE. THE VIABAHN® DEVICE REACHED THE TARGET LESION AND DEPLOYMENT WAS INITIATED. THE DEPLOYMENT LINE STARTED UNRAVELING, BUT BECAME STUCK AND THE VIABAHN® DEVICE STARTED BOW STRINGING. THE PHYSICIAN RELEASE THE DEPLOYMENT LINE TENSION AND WAS ABLE TO WITHDRAW THE CONSTRAINED DEVICE BACK THROUGH THE SHEATH WITH NO ISSUES AND NO HARM TO PATIENT. THE PHYSICIAN COMPLETED THE PROCEDURE BY PERFORMING ANGIOPLASTY. PHYSICIAN STATED HE BELIEVES THE DEPLOYMENT LINE MIGHT HAVE BEEN CAUGHT ON SOME PART OF THE STENT. AFTER DEVICE WAS REMOVED, PHYSICIAN TRIED TO DEPLOY THE DEVICE ON THE BACK TABLE, BUT THE LINE REMAINED STUCK.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22137597 ↗
• MalfunctionApr 18, 2025Break; Difficult or Delayed Activation; Break; Difficult or Delayed Activation

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR A SEVERE VASCULATURE IN THE RIGHT COMMON ILIAC ARTERY USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE). IT WAS REPORTED THAT DURING THE PROCEDURE, WHILE ADVANCING THE VIABAHN DEVICE OVER A TERUMO GLIDEWIRE ADVANTAGE THROUGH A 7FR PINNACLE SHEATH, IT WAS OBSERVED THAT THE CATHETER TIP BROKE OFF INSIDE THE PATIENTS RIGHT ILIAC. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE DETACHED TIP USING A SNARE AND PROCEEDED TO PULL THE STRING TO DEPLOY THE VIABAHN DEVICE. THE VIABAHN DEVICE DEPLOYED SUCCESSFULLY, AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS. IT REMAINS UNKNOWN WHETHER THE TARGET LESION WAS PREDILATED, BUT THE PHYSICIAN WAS ABLE TO REACH THE TREATMENT SITE. THE CAUSE OF THE CATHETER TIP DETACHMENT REMAINS UNCERTAIN. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867280 ↗
• MalfunctionDec 10, 2024Loss of or Failure to Bond; Material Separation; Detachment of Device or Device Component; Loss of or Failure to Bond; Material Separation; 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 IN THE HYPOGASTRIC ARTERY DURING TREATMENT OF AN AORTIC ANEURYSM. IT WAS REPORTED: THE DEVICE WAS PREPPED AS NORMAL AND VERY TORTUOUS ANATOMY. THE VSX DEVICE WAS ADVANCED THOUGH A 12FR GORE® DRYSEAL FLEX INTRODUCER SHEATH OVER AN 0.035" ROSEN GUIDE WIRE AND DEPLOYED WITHOUT ISSUE. HOWEVER, DURING THE REMOVAL OF THE DELIVERY CATHETER THE DISTAL TIP GOT HUNG UP ON THE INTRODUCER SHEATH, THE PHYSICIAN FELT RESISTANCE AND CONTINUED TO PULL. AN ANGIOGRAM WAS PERFORMED, AND A FOREIGN BODY WAS IDENTIFIED ON THE GUIDE WIRE. THE DELIVERY CATHETER WAS INSPECTED AND SHOWED THE DISTAL TIP WAS NOT PRESENT. WITH THE DISTAL TIP STILL ON THE GUIDEWIRE, IT WAS REMOVED FROM PATIENT WITH A SNARE. ALL PARTS WERE ACCOUNTED FOR, AND THE PROCEDURE WAS COMPLETED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892722 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON SEPTEMBER 17, 2024, A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AORTIC COMPONENT (AC), GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG), AND FOUR GORE ® VIABAHN® (VSX) DEVICES WERE USED TO TREAT A PATIENT THAT HAD A CONGENITAL COARCTATION OF THE AORTA, THAT HAD LED TO A 9CM AORTIC ARCH ANEURYSM. THE TBE AC WAS SUCCESSFULLY DEPLOYED DESCENDING THORACIC AORTA TO TREAT THE ANEURYSM AND THE VSX DEVICES WERE PLACED IN THE PORTAL OF THE TBE AC AND EXTENDED TO THE LEFT SUBCLAVIAN ARTERY (LSA). THE CTAG DEVICE WAS USED TO EXTEND THE TBE AC PROXIMALLY UP TO THE LEVEL OF THE LEFT COMMON CAROTID ARTERY (LCCA). PATIENT HAD HEPARIN ADMINISTERED TO MAINTAIN ACT ABOVE 250 DURING THE INDEX TBE PROCEDURE ON (B)(6) 2024. THE PATIENT TOLERATED THE ENDOVASCULAR PROCEDURE. ON (B)(6) 2024, THE PATIENT RECEIVED A LARGER DOSE OF UNFRACTIONATED HEPARIN DURING A PLANNED OPEN AORTIC ARCH RECONSTRUCTION. AFTER THE OPERATION ON (B)(6) 2024, THE PATIENT EXPERIENCED A STEADY DECREASE IN PLATELET COUNT. THE PATIENT HAD A HIT POSITIVE TEST ON (B)(6) 2024 AND THE USE OF HEPARIN WAS DISCONTINUED. ADDITIONALLY, THE PATIENT HAD LEFT ARM SUPERFICIAL VENOUS THRO

  Patient problems: Ischemia Stroke; Thrombocytopenia

  MAUDE report 20524325 ↗
• InjuryOct 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) AORTIC COMPONENT (AC), GORE® TAG® CONFORMABLE THORACIC STENT GRAFT (CTAG), AND FOUR GORE ® VIABAHN® (VSX) DEVICES WERE USED TO TREAT A PATIENT THAT HAD A CONGENITAL COARCTATION OF THE AORTA, THAT HAD LED TO A 9CM AORTIC ARCH ANEURYSM. THE TBE AC WAS SUCCESSFULLY DEPLOYED DESCENDING THORACIC AORTA TO TREAT THE ANEURYSM AND THE VSX DEVICES WERE PLACED IN THE PORTAL OF THE TBE AC AND EXTENDED TO THE LEFT SUBCLAVIAN ARTERY (LSA). THE CTAG DEVICE WAS USED TO EXTEND THE TBE AC PROXIMALLY UP TO THE LEVEL OF THE LEFT COMMON CAROTID ARTERY (LCCA). PATIENT HAD HEPARIN ADMINISTERED TO MAINTAIN ACT ABOVE 250 DURING THE INDEX TBE PROCEDURE ON (B)(6) 2024. THE PATIENT TOLERATED THE ENDOVASCULAR PROCEDURE. ON (B)(6) 2024, THE PATIENT RECEIVED A LARGER DOSE OF UNFRACTIONATED HEPARIN DURING A PLANNED OPEN AORTIC ARCH RECONSTRUCTION. AFTER THE OPERATION ON (B)(6) 2024, THE PATIENT EXPERIENCED A STEADY DECREASE IN PLATELET COUNT. THE PATIENT HAD A HIT POSITIVE TEST ON SEPTEMBER 23 AND THE USE OF HEPARIN WAS DISCONTINUED. ADDITIONALLY, THE PATIENT HAD LEFT ARM SUPERFICIAL VENOUS THROMBOSIS

  Patient problems: Ischemia Stroke; Thrombocytopenia

  MAUDE report 20523347 ↗
• InjuryJul 2, 2024Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A 10 MM X 5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED FOR USE TO LINE A FISTULA IN THE UPPER ARM FOR AV ACCESS. THE PHYSICIAN REPORTED THAT THERE WAS DIFFICULTY TO ADVANCE THE VIABAHN DEVICE THROUGH A 8 F TERUMO PINNACLE INTRODUCER SHEATH DUE TO SEVERAL FACTORS SUCH AS: TORTUOUS ANATOMY, PSEUDOANEURYSM, FISTULA, AND CONTRALATERAL VENOUS APPROACH WITH A 0.018¿ GLIDEWIRE ADVANTAGE (LESS STIFF). IT WAS REPORTED THE VIABAHN DEVICE THEN BEGAN TO BOW-STRING, ULTIMATELY, THE VIABAHN DEVICE CATHETER BROKE AT THE TRANSITION AT THE DISTAL END OF THE CATHETER TO THE PROXIMAL END OF THE VIABAHN DEVICE STENT GRAFT. THE PHYSICIAN THEN HAD TO SURGICALLY CUT DOWN TO RETRIEVE THE VIABAHN DEVICE. NO COMPONENTS OF THE VIABAHN DEVICE WERE LEFT INSIDE THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 10 MM X 10 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19657316 ↗
• InjuryAug 30, 2021Obstruction of Flow; Obstruction of Flow

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, PATIENT WITH HISTORY OF PERIPHERAL ARTERY DISEASE RECEIVED ENDOVASCULAR TREATMENT IN BOTH LEGS. DURING THIS PROCEDURE, 11 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICES) WERE PLACED FROM THE START OF SUPERFICIAL FEMORAL ARTERY (BELOW THE PROFUNDA ARTERY) TO BELOW-KNEE POPLITEAL ARTERY. THE IMPLANTED VSX DEVICES WERE POST-DILATED. AT THE END OF THIS PROCEDURE, ALL VSX DEVICES WERE PATENT AND PATIENT HAD THREE BRISK VESSEL RUN-OFFS IN BOTH FEET. PATIENT PRESENTED WITH COMPLAINT OF LEFT LEG CLAUDICATION. EXAMINATION REVEALED ONE OF THE VSX DEVICES HAD OCCLUDED AND THROMBECTOMY WAS PERFORMED ON (B)(6) 2021. AS REPORTED, MULTIPLE SIZES OF FOGARTY BALLOON DEVICES WERE USED TO REMOVE THE THROMBUS. DURING THIS INTERVENTION, AN UNKNOWN SUBSTANCE WAS REMOVED WITH THE THROMBUS. AT THE CONCLUSION OF THE PROCEDURE, THE VSX DEVICES WERE ALL PATENT, BUT ONLY ONE VESSEL RUN-OFF TO THE LEFT FOOT WAS OBSERVED. NO FURTHER ACTIONS WERE TAKEN BY PHYSICIAN AT THIS TIME. THE REMOVED SPECIMEN WAS RETAINED BY AT THE HOSPITAL'S PATHOLOGY DEPARTMENT. ADDITIONAL INFORMATION: THE PHYSICIAN REPORTED THE SAMPLE WAS FOUND TO BE HUMAN T

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12385623 ↗
• MalfunctionJul 14, 2021Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A PATIENT PRESENTED WITH STENOSIS IN THE LEFT BASILIC VEIN AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE PHYSICIAN WAS ABLE TO ADVANCE THE DEVICE TO THE TARGET LESION WITHOUT ISSUE USING AN 8FR SHEATH AND 0.035" GUIDEWIRE. WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE, THE CENTER OF THE DEVICE WOULD NOT FULLY EXPAND. THE PHYSICIAN ATTEMPTED TO EXPAND THE DEVICE USING POST DEPLOYMENT BALLOONING, BUT WAS UNSUCCESSFUL. BLOOD FLOW WAS CONFIRMED THROUGH THE DEVICE. THE DEVICE REMAINS IMPLANTED AND THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12165985 ↗