GORE VIABAHN Endoprosthesis with Heparin VBJR081002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00733132623822), received between May 6, 2019 and Jan 22, 2026 — classified as 4 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (6 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2026Activation Failure

  THE FOLLOWING INFORMATION WAS PROVIDED TO GORE: ON (B)(6) 2025, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN AN UNKNOWN ETIOLOGY DURING TREATMENT OF PERIPHERAL ARTERIAL DISEASE (PAD). REPORTEDLY, AFTER THE INTRODUCER SHEATH (MANUFACTURER AND SIZE UNKNOWN) AND VSX DEVICE WERE ADVANCED ACROSS THE LESION, THE DEPLOYMENT LINE WAS PULLED AND COMPLETELY REMOVED FROM THE PATIENT. IT WAS THEN OBSERVED THAT THE VSX DEVICE HAD NO DEVICE EXPANSION. WITH NO DEVICE EXPANSION THE PHYSICIAN REMOVED THE VSX DEVICE AND INTRODUCER SHEATH IN TANDEM. AFTER REMOVAL, THE STENT WAS OBSERVED TO HAVE NO CONSTRAINMENT ZIPPER AND REMAINED WITH NO DEVICE EXPANSION. THE PROCEDURE WAS COMPLETED WITH A NON-GORE DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24150374 ↗
• MalfunctionJan 16, 2026Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR AN OUTFLOW STENOSIS AV FISTULA WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED TO BE PLACED IN THE BRACHIAL VEIN. USING A 7FR INTRODUCER SHEATH (UNSPECIFIED MANUFACTURE) AND A 0.018 GUIDEWIRE (UNSPECIFIED MANUFACTURE), THE PHYSICIAN WAS ABLE TO REACH THE TARGET TREATMENT AREA WITHOUT ANY RESISTANCE. THE PHYSICIAN INITIATED DEPLOYMENT BY PULLING THE DEPLOYMENT LINE HOWEVER, THE VIABAHN DEVICE WOULD NOT DEPLOY. SOME BOW STRINGING WAS NOTICED ON VIABAHN DEVICE WHEN ATTEMPTING TO DEPLOY. THE PHYSICIAN WITHDREW THE CONSTRAINED VIABAHN DEVICE THROUGH THE SHEATH AND THE PROCEDURE WAS COMPLETED USING ANOTHER VIABAHN DEVICE. THERE WERE REPORTS OF NO PATIENT HARM DURING THE PROCEDURE. IT WAS REPORTED THAT THERE WAS SOME STENOSIS PRESENT AT THE TARGET TREATMENT AREA. IT WAS REPORTED THAT THE DEPLOYMENT LINE WAS NOT STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24103155 ↗
• InjuryOct 15, 2025Detachment of Device or Device Component; Activation Failure; Detachment of Device or Device Component; Activation Failure

  ON (B)(6) 2025, TREATMENT WAS PERFORMED DUE TO A STENOTIC LESION AND DE-CLOTTING OF FISTULA IN THE PATIENT¿S LEFT UPPER ARM. THE TARGET TREATMENT AREA WAS PRE-DILATED WITH 8X4 MUSTANG BALLOON. A 7FR X 6CM TERUMO SHEATH WAS USED TO ADVANCE THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) OVER AN .018 X 200CM V-18 CONTROLWIRE¿ GUIDEWIRE. DEPLOYMENT WAS STARTED WHEN THE DEPLOYMENT LINE BROKE AFTER ABOUT SIX INCHES OF UNRAVELING. THE PHYSICIAN REMOVED THE CONSTRAINED VIABAHN® DEVICE THROUGH THE SHEATH WITH NO ISSUES. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303436 ↗
• MalfunctionJun 26, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR A POPLITEAL ANEURYSM WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS ATTEMPTED TO BE USED IN THE POPLITEAL ARTERY. IT WAS REPORTED DURING THE PROCEDURE, THE VIABAHN DEVICE WAS ADVANCED THROUGH A TERUMO 7FR INTRODUCER SHEATH OVER A COMMAND .014" GUIDEWIRE. THE VIABAHN DEVICE REACHED THE INTENDED TREATMENT SITE, AND THE PHYSICIAN BEGAN THE DEPLOYMENT PROCESS BY PULLING THE DEPLOYMENT LINE. REPORTEDLY, THE DEPLOYMENT LINE WAS PULLED WITH STEADY SPEED. HOWEVER, BEFORE REACHING THE DEVICE EXPANSION STAGE, THE DEPLOYMENT LINE UNEXPECTEDLY STOPPED UNRAVELING. THE PHYSICIAN ATTEMPTED TO PULL THE DEPLOYMENT LINE GENTLY, BUT THE VIABAHN DEVICE DID NOT CONTINUE TO DEPLOY. CONCERNED ABOUT THE POTENTIAL LINE BREAKAGE AND NOTICING A SLIGHT BOWING OF THE VIABAHN DEVICE, THE PHYSICIAN REPLACED THE GUIDEWIRE WITH A GLIDEWIRE ADVANTAGE .018". DESPITE THIS ADJUSTMENT, THE DEPLOYMENT LINE REMAINED STUCK. AT THIS TIME, THE VIABAHN DEVICE WAS REMOVED FROM THE PATIENT'S BODY OVER THE GUIDEWIRE THE SAME WAY IT WENT IN. THE PROCEDURE WAS COMPLETED USING A NEW 8MM X 7.5CM VIABAHN DEVICE. THIS OVERLAPPED WITH AN 8MM X

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342981 ↗
• MalfunctionMar 25, 2025Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN AN UPPER ARM FISTULA. AFTER THE VSX DEVICE WAS ADVANCED THROUGH A 7 FR TERUMO INTRODUCER SHEATH OVER A 0.018' NITREX GUIDE WIRE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE. HOWEVER, AFTER THE PHYSICIAN ATTEMPTED TO PULL THE DEPLOYMENT LINE, VSX DEVICE WOULD NOT DEPLOY AND WAS REMOVED. AN ADDITIONAL VSX DEVICE WAS SUCCESSFULLY DEPLOYED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691986 ↗
• InjuryDec 12, 2024Premature Activation; Premature Activation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, PATIENT PRESENTED FOR TREATMENT OF AN ANEURYSMAL LEFT HYPOGASTRIC ARTERY. ACCESS WAS FROM THE RIGHT GROIN. AS REPORTED, THE PHYSICIAN USED COILS FOR A PORTION OF THE ANEURYSM, THEN DEPLOYED A 6 X 5 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX DEVICE) IN THE DISTAL HYPOGASTRIC ARTERY. A 7FR TOURGUIDE STEERABLE SHEATH WAS USED TO ADVANCE AN 8 X 10 VSX DEVICE OVER A .035 MEIER WIRE FOR IMPLANT WITHIN THE HYPOGASTRIC ARTERY. AS REPORTED, THE VSX DEVICE WAS PULLED BACK THROUGH THE SHEATH AND ONTO THE BACK TABLE SO THE SHEATH CAN BE READJUSTED. AFTER THE SHEATH WAS MANIPULATED, THE SAME VSX DEVICE WAS ADVANCED AGAIN INTO THE HYPOGASTRIC ARTERY. AS THE VSX DEVICE WAS ADVANCED BEYOND THE SHEATH, THE DEVICE STARTED EXPANDING UNEXPECTEDLY. IT WAS REPORTED THE DEPLOYMENT KNOB WAS NOT UNSCREWED. ATTEMPTS WERE MADE TO PULL THE EXPANDING DEVICE BACK INTO THE SHEATH, BUT THIS WAS NOT SUCCESSFUL. ABOUT HALF OF THE DEVICE REMAINED OUTSIDE THE SHEATH. CONSEQUENTLY, THE SHEATH, DEVICE AND GUIDEWIRE WERE PULLED OUT TOGETHER. THIS RESULTED IN DAMAGE TO THE COMMON FEMORAL ARTERY ACCESS SITE. THE PHYSICIAN DID A CUTDOWN AND AN OPEN

  Patient problems: Perforation of Vessels

  MAUDE report 20917057 ↗
• MalfunctionApr 16, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT IN AN ARTERIOVENOUS (AV) ACCESS FISTULA OR GRAFT (UNKNOWN WHICH) IN THE UPPER ARM USING AN 8 MM X 10 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE). IT WAS REPORTED THE PHYSICIAN ADVANCED THE DELIVERY CATHETER THROUGH AN UNKNOWN SIZE / BRAND SHEATH OVER AN 0.018" GUIDEWIRE (BRAND UNKNOWN) TO THE TARGET TREATMENT SITE. IT IS UNKNOWN IF THE TREATMENT AREA WAS PREDILATED. REPORTEDLY, THE PHYSICIAN PULLED THE DEPLOYMENT STRING, BUT THE ENDOPROSTHESIS DID NOT DEPLOY. THE PROCEDURE WAS COMPETED USING ANOTHER 8 MM X 10 CM VIABAHN® DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19122127 ↗
• MalfunctionMar 19, 2024Difficult or Delayed Activation; Difficult or Delayed Activation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2024, THE PATIENT UNDERWENT A DECLOTTING TREATMENT OF AN ARTERIOVENOUS FISTULA IN THE UPPER LEFT ARM USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE). NO CALCIFICATION WAS PRESENT IN THE TARGET TREATMENT SITE, ONLY SOME THROMBOSIS. IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO REACH THE TARGET TREATMENT SITE BY USING AN UNKNOWN GUIDEWIRE AND SHEATH, WHERE THE ACCESS POINT WAS THE WRIST. THE PHYSICIAN WENT TO PULL THE DEPLOYMENT LINE AND WAS ONLY ABLE TO PULL AN INCH WORTH OF STRING BEFORE MEETING RESISTANCE. THE PHYSICIAN TRIED PULLING A COUPLE OF TIME WITH NO SUCCESS. THE VIABAHN DEVICE WAS WITHDRAWN FROM THE PATIENT WITH NO ISSUES. THERE WAS NO DEVICE EXPANSION AS THE VIABAHN DEVICE REMAINED CONSTRAINED ON THE DELIVERY SYSTEM AND THE DEPLOYMENT LINE REMAINED INTACT. 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 18935751 ↗
• MalfunctionNov 14, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT PRESENTED WITH AN OCCLUDED LEFT SUPERFICIAL FEMORAL ARTERY (SFA) AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. ACCESS FOR THE PROCEDURE WAS FROM THE COMMON FEMORAL ARTERY DOWN TO THE PROXIMAL POPLITEAL ARTERY AND THE PHYSICIAN PROCEEDED TO ACCESS THROUGH THE ANTERIOR TIBIAL ARTERY WITH A 7 FR SHEATH. THE VIABAHN DEVICE WAS LOADED ONTO AN 0.018 GUIDEWIRE, BUT COULD NOT ADVANCE WHILE IN THE TIBIAL PERONEAL TRUNK. THE PHYSICIAN DECIDED TO REMOVE THE VIABAHN DEVICE, BUT IT WAS FOUND TO BE STUCK IN THE SHEATH. DURING REMOVAL ATTEMPTS, THE TIP OF THE CATHETER PARTIALLY SEPARATED BUT DID NOT COMPLETELY DETACH FROM THE DELIVERY SYSTEM. THE DEPLOYMENT LINE ALSO BROKE DURING REMOVAL ATTEMPTS. THERE WAS NO REPORTED DEVICE DEPLOYMENT. THE PHYSICIAN SWITCHED TO AN 8 FR SHEATH AND REMOVED THE VIABAHN DEVICE AND DELIVERY SYSTEM BY RE-SHEATHING AND PULLING THE DEVICE OUT OF THE PATIENT. THE PROCEDURE WAS COMPLETED WITH TWO ALTERNATE VIABAHN DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15794054 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022 A PATIENT PRESENTED FOR AN AV ACCESS PROCEDURE UTILIZING THREE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE DEVICES. THE PHYSICIAN SUCCESSFULLY PLACED THE FIRST TWO VIABAHN DEVICES AND PROCEEDED TO PLACE A THIRD OVERLAPPING VIABAHN TO EXTEND INTO THE AXILLARY VEIN. THE VIABAHN DEVICE WAS ADVANCED OVER AN 0.014" ABBOTT WHISPER GUIDEWIRE AND ADVANCED TO THE INTENDED LOCATION. WHEN THE PHYSICIAN PULLED THE DEPLOYMENT LINE THE VIABAHN DEVICE BEGAN TO BOW-STRING DUE TO THE LACK OF STIFFNESS IN THE GUIDEWIRE AND LACK OF APPOSITION. THE DEPLOYMENT LINE THEN REPORTEDLY BROKE. THE VIABAHN DEVICE WAS ABLE TO BE FULLY DEPLOYED, BUT DUE TO THE OVERSIZED VEIN AND THE LACK OF GUIDEWIRE SUPPORT, THE VIABAHN DEVICE FOLDED OVER ON ITSELF AND TRAPPED THE GUIDEWIRE AND DEVICE CATHETER WITHIN THE PATIENTS VESSEL. THE PATIENT WAS CONVERTED TO AN OPEN PROCEDURE AND THE VIABAHN DEVICE AND ALL DEVICE COMPONENTS WERE REMOVED FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15793186 ↗
• InjuryJun 23, 2022Collapse; Obstruction of Flow; Collapse; Obstruction of Flow

  ORIGINAL PSTS EVENT # 44892 GRT 10-11 STUDY, PATIENT ID (B)(6). INFORMATION OBTAINED FROM IMEDIDATA ¿ STENT PLACED IN SMA DURING INDEX PROCEDURE (UNKNOWN DEVICE) COMPRESSED WITH REINTERVENTION REQUIRED OF ADDITIONAL STENT PLACEMENT IN SMA (UNKNOWN DEVICE). INFORMATION FROM STUDY MANAGER FOR THE IDENTITY OF THE DEVICE/DEVICES IMPLANTED WITHIN THE SMA WAS REQUESTED BUT NO FURTHER INFORMATION WAS OBTAINED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 14794768 ↗
• MalfunctionMar 28, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022 A PATIENT PRESENTED WITH BILATERAL SUPERFICIAL FEMORAL ARTERY (SFA) DISEASE AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX) DEVICE. THE VSX DEVICE WAS SUCCESSFULLY DELIVERED AND IMPLANTED IN THE PROXIMAL SFA. AFTER IMPLANTATION, THE PHYSICIAN ATTEMPTED TO WITHDRAW THE DELIVERY SYSTEM BACK INTO THE SHEATH FOR REMOVAL AND THE DISTAL TIP BECAME SEPARATED FROM THE DELIVERY CATHETER. THE PHYSICIAN WAS ABLE TO SNARE THE DISTAL OLIVE TIP AND SUCCESSFULLY REMOVE IT FROM THE PATIENT. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929387 ↗
• MalfunctionApr 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A DIABETIC PATIENT UNDERWENT TREATMENT DUE TO AN AV FISTULA IN THE LEFT UPPER ARM. DURING THE PROCEDURE, A 7FR 10CM TERUMO SHEATH WAS USED TO ADVANCE AN 8 X 10 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) OVER AN .018 V18 WIRE. AS REPORTED, THE PHYSICIAN NOTED THERE WAS A KINK AT THE TRANSITION AREA OF THE DELIVERY CATHETER PRIOR TO DEVICE INSERTION. HOWEVER, PROCEDURE CONTINUED AND AS DEVICE WAS BEING DELIVERED TO TARGET TREATMENT AREA, THE DELIVERY CATHETER WAS PULLED BACK SLIGHTLY THROUGH THE SHEATH. AT THIS TIME, THE DISTAL TIP BROKE OFF THE CATHETER. A NEW DEVICE WAS USED TO PIN THE DISTAL TIP AGAINST THE VESSEL WALL. THE VIABAHN DEVICE WAS THEN DEPLOYED AT OTHER THAN THE INTENDED LOCATION. A NEW GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS ABLE TO BE ADVANCED TO TREATMENT AREA. DEVICE WAS DEPLOYED AND PROCEDURE ENDED WITH GOOD RESULTS. THE PATIENT WAS NOT ADVERSELY IMPACTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11672192 ↗
• MalfunctionMar 17, 2020Material Separation; Activation, Positioning or Separation Problem; Material Separation; Activation, Positioning or Separation Problem

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR SFA OCCLUSIVE TREATMENT. THE FIRST 2 GORE® VIABAHN® ENDOPROSTHESIS WERE PLACED WITHOUT ISSUE. THE THIRD GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED INTO POSITION AND DEPLOYMENT STARTED. THE DEVICE EXPERIENCED NO EXPANSION AND THE DEPLOYMENT LINE BROKE WHILE BEING PULLED. THE DOCTOR WAS ABLE TO BACK THE DEVICE BACK INTO THE SHEATH AND REMOVE IT FROM THE PATIENT WITHOUT ISSUE. ANOTHER GORE® VIABAHN® ENDOPROSTHESIS WAS SUCCESSFULLY ADVANCED AND DEPLOYED.

  Patient problems: Occlusion

  MAUDE report 9843463 ↗
• MalfunctionMay 6, 2019Failure to Unfold or Unwrap; Device Dislodged or Dislocated; Failure to Unfold or Unwrap; Device Dislodged or Dislocated

  THE FOLLOWING WAS REPORTED TO GORE: THE GORE® VIABAHN® ENDOPROSTHESIS WAS PLACED IN THE SMA AS A SNORKEL. WHEN THE DOCTOR BEGAN PULLING THE DEPLOYMENT LINE THE DEVICE OPENED APPROXIMATELY 1/2 AND STOPPED OPENING. THE DISTAL END OF THE DEVICE HAD OPENED BUT THE PROXIMAL END NEVER OPENED. THE DOCTOR ADVANCED THE SHEATH OVER THE DEVICE AND ATTEMPTED TO REMOVE THE DEVICE. THE ATTEMPT MOVED THE DEVICE INTO THE SUBCLAVIAN ARTERY WHERE THE DEVICE WAS EVENTUALLY PULLED FROM THE PATIENT. ANOTHER GORE® VIABAHN® ENDOPROSTHESIS WAS SUCCESSFULLY USED TO COMPLETE THE TREATMENT. THE DOCTOR CLOSED THE ARTERY IN THE NORMAL FASHION WITH NO SERIOUS INJURY TO THE PATIENT.

  Patient problems: No Information

  MAUDE report 8584618 ↗