GORE VIABAHN Endoprosthesis with Heparin VBHR101002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00733132646043), received between Jun 15, 2022 and Jun 26, 2026 — classified as 4 injuries, 8 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2026Device Endoleak

  ON (B)(6), 2026, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF A ZONE 9 INFRARENAL ABDOMINAL AORTIC ANEURYSM USING A GORE® EXCLUDER® CONFORMABLE TRUNK-IPSILATERAL LEG ENDOPROSTHESIS IN CONJUNCTION WITH GORE® EXCLUDER® CONTRALATERAL LEG ENDOPROSTHESIS DEVICES. THE PROCEDURE WAS INITIALLY PLANNED TO INCLUDE A UNILATERAL ILIAC BRANCH ENDOPROSTHESIS (IBE); HOWEVER, DUE TO TORTUOUS ILIAC ANATOMY, THIS APPROACH WAS DETERMINED TO BE NOT FEASIBLE. DURING VASCULAR ACCESS PREPARATION USING PROGLIDE, AND PRIOR TO INITIATION OF THE INTENDED ENDOVASCULAR REPAIR, A RUPTURE OF THE RIGHT EXTERNAL ILIAC ARTERY OCCURRED. AS THE PATIENT¿S BLOOD PRESSURE BEGAN TO DECREASE, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS DEPLOYED ACROSS THE RIGHT EXTERNAL ILIAC ARTERY TO CONTROL BLEEDING. FOLLOWING HEMODYNAMIC STABILIZATION, THE TREATING TEAM PROCEEDED WITH A STANDARD EVAR, WHICH INCLUDED COIL EMBOLIZATION AND COVERAGE OF THE RIGHT HYPOGASTRIC ARTERY, GIVEN THE ANATOMICAL CONSTRAINTS AS WELL AS THE INCREASING PROCEDURAL COMPLEXITY AND DURATION. FINAL INTRAOPERATIVE IMAGING DEMONSTRATED SATISFACTORY RESULTS, AND THE PATIENT WAS TRANSFERRED TO RECOVERY. POSTOPERATIVELY,

  Patient problems: Clinical Endoleak

  MAUDE report 25643414 ↗
• MalfunctionJun 4, 2026Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2026, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE CELIAC ARTERY DURING TREATMENT OF AN AORTIC ANEURYSM BEING TREATED WITH A GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS (TAMBE DEVICE). REPORTEDLY, AFTER THE DEVICE WAS ADVANCED OVER AN 0.035" ROSEN GUIDE WIRE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE VSX DEVICE. HOWEVER, AFTER DEPLOYMENT WAS INITIATED THE DEPLOYMENT LINE GOT HUNG UP AND THE PHYSICIAN WAS UNABLE TO COMPLETE DEPLOYMENT. WITH NO DEVICE EXPANSION, THE DELIVERY SYSTEM WAS REMOVED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394709 ↗
• MalfunctionMar 23, 2026Detachment of Device or Device Component

  ON (B)(6) 2026, THE PATIENT UNDERWENT A PROCEDURE FOR AN UNKNOWN ETIOLOGY WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS IMPLANTED IN AN UNKNOWN ANATOMICAL LOCATION. THE PHYSICIAN WAS ABLE TO DEPLOY A VIABAHN DEVICE IN THE TARGET TREATMENT AREA WHILE GOING THROUGH A CORDIS 9 FR BRITE TIP® SHEATH INTRODUCER AND OVER A 0.035" GUIDEWIRE. AFTER WITHDRAWING THE VIABAHN DEPLOYMENT CATHETER, A SECTION OF THE LAST FEW CM OF THE DEPLOYMENT CATHETER WAS NOTICED INSIDE OF THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN CATHETER SEGMENT FROM THE PATIENT. THERE WERE NO ADVERSE PATIENT OUTCOMES AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24667228 ↗
• MalfunctionMar 16, 2026Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: ON OR ABOUT (B)(6) 2026, A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) MODIFICATION WAS PERFORMED. A 9FR BRITE TIP INTRODUCER SHEATH WAS USED TO ADVANCE A 10MM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) OVER AN .035 WIRE (UNSPECIFIED MANUFACTURER). THE VIABAHN® DEVICE WAS IMPLANTED TO EXTEND THE PRE-EXISTING STENT (UNKNOWN MANUFACTURER). THE VIABAHN® DEVICE WAS DEPLOYED WITH NO ISSUES. THE VIABAHN® DELIVERY CATHETER WAS THEN REMOVED THROUGH THE SHEATH WITHOUT ANY ISSUES OR NOTICEABLE EFFORT REQUIRED TO REMOVE IT. DURING SUBSEQUENT IMAGING, THE PHYSICIAN NOTICED A FOREIGN BODY STILL REMAINED IN THE PATIENT. USING A SNARE, THE DISTAL SEGMENT OF THE DELIVERY CATHETER WAS EASILY RETRIEVED. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT AND THE PROCEDURE WAS COMPLETED WITHOUT ANY FURTHER ISSUES. AS REPORTED, THE PHYSICIAN STATED HE DID NOT FEEL ANY RESISTANCE TO INDICATE A POSSIBLE CATHETER BREAK.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24608179 ↗
• MalfunctionNov 25, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE OF UNKNOWN ETIOLOGY AT AN UNSPECIFIED ANATOMICAL LOCATION, DURING WHICH A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED FOR IMPLANTATION. ACCESS WAS OBTAINED VIA THE GROIN USING AN 8 FR INTRODUCER SHEATH (MANUFACTURER UNKNOWN) AND AN UNKNOWN GUIDEWIRE. THE PHYSICIAN INITIATED DEPLOYMENT BY PULLING THE DEPLOYMENT LINE OF THE VIABAHN DEVICE; HOWEVER, THE DEVICE DID NOT DEPLOY. ADDITIONAL ATTEMPTS TO PULL THE DEPLOYMENT LINE WITH INCREASED FORCE WERE UNSUCCESSFUL. THE PHYSICIAN SUBSEQUENTLY WITHDREW THE VIABAHN DEVICE AND COMPLETED THE PROCEDURE USING A NEW VIABAHN DEVICE. THERE WAS NO REPORTED IMPACT TO THE PATIENT. THE PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF THE DEPLOYMENT FAILURE. THERE WERE NO INDICATIONS OF SIGNIFICANT TORTUOSITY OR CHALLENGING ANATOMY. AFTER REMOVAL OF THE CATHETER AND SHEATH, THE PHYSICIAN ATTEMPTED TO DEPLOY THE VIABAHN DEVICE OUTSIDE THE BODY, BUT IT STILL FAILED TO DEPLOY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23649022 ↗
• MalfunctionNov 3, 2025Break; Break

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR AN EXTERNAL ILIAC PSEUDOANEURYSM FROM A PRIOR PROCEDURE USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. IT WAS REPORTED THAT THE PHYSICIAN ACCESSED THE TREATMENT VIA A CONTRALATERAL APPROACH USING EITHER AN 8F TERUMO SHEATH (25CM) OR CORDIS BRITE TIP SHEATH INTRODUCER (23 CM), OVER AN .035" TERUMO STIFF GLIDEWIRE. REPORTEDLY, THERE WAS INITIAL DIFFICULTY CROSSING THE TARGET TREATMENT AREA, WHICH HAD PREVIOUSLY BEEN TREATED¿POSSIBLY WITH AN ENDARTERECTOMY. AT THE TARGET SITE, THE ENDOPROSTHESIS WAS DEPLOYED IN THE INTENDED LOCATION. UPON WITHDRAWAL OF THE DELIVERY SYSTEM, IT WAS REPORTED THE DELIVERY CATHETER FOLDED IN HALF AND BROKE IN HALF. A PENUMBRA LIGHTNING CATHETER WAS USED TO ASPIRATE AND RETRIEVE THE SEPARATED PORTION BACK INTO THE SHEATH. BOTH THE CATHETER AND SHEATH WERE REMOVED SUCCESSFULLY, AND THE ENDOPROSTHESIS REMAINED IN PLACE. THE PHYSICIAN WAS UNCERTAIN ABOUT THE CAUSE OF THE DELIVERY SYSTEM SEPARATION AND REPORTEDLY DID NOT OBSERVE ANY KINKING OF THE CATHETER. IT WAS REPORTED THERE WAS NO REPORTED IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23452285 ↗
• MalfunctionJul 15, 2025Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON JUNE 17, 2025, A 10MM X 10CM GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE UPPER LEFT ARM DURING TREATMENT OF STENOSIS ON THE VEIN SIDE OF A FISTULA. AFTER THE DEVICE WAS ADVANCED OVER AN 0.035" STIFF TERUMO GLIDEWIRE, THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE. HOWEVER, AFTER THE DEPLOYMENT WAS INITIATED, THE DEPLOYMENT LINE GOT HUNG UP AT THE TURNAROUND AND STARTED TO BOWSTRING. WITH NO DEVICE EXPANSION, THE PHYSICAN REMOVED THE DEVICE THROUGH THE INTRODUCER SHEATH. A NEW 10MM X 10CM VSX DEVICE WAS SUCCESSFULLY IMPLANTED TO COMPLETE THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22511567 ↗
• MalfunctionJul 2, 2025Material Invagination; Material Invagination

  THE FOLLOWING WAS REPORTED TO GORE FROM GORE IMAGING: ON (B)(6) 2025, THIS 85-YEAR-OLD MALE PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR REINTERVENTION OF AN ENDOLEAK TYPE 1B. THE PATIENT WAS TREATED WITH A GORE®¿EXCLUDER®¿CONFORMABLE AAA ENDOPROSTHESIS AORTIC EXTENDER DEVICE IN THE INFRARENAL ABDOMINAL AORTA, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) IN THE RIGHT EXTERNAL ILIAC ARTERY, AND TWO VSX DEVICES IN THE RIGHT INTERNAL ILIAC ARTERY. THE SITES WERE ACCESSED PERCUTANEOUSLY ON THE RIGHT AND BY CUT-DOWN ON THE LEFT. THE GORE® DEVICES WERE SUCCESSFULLY NAVIGATED TO THE INTENDED LOCATIONS AND SUCCESSFULLY DEPLOYED. THERE WERE NO ACCESS-RELATED COMPLICATIONS. THE PATIENT HAD A MILD STROKE BUT WAS DISCHARGED HOME FROM THE HOSPITAL ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT HAD A CT ANGIOGRAM. REVIEW OF THE CT SHOWED AN ENDOLEAK OF INDETERMINATE TYPE ENDOLEAK AND COMPRESSION/INFOLDING RELATED TO VSX REGISTRY DEVICE. ON (B)(6) 2025, THE PATIENT HAD A CT ANGIOGRAM AND WAS NOTED TO HAVE A TYPE 2 ENDOLEAK, AND CONTINUED COMPRESSION/INFOLDING RELATED TO THE VSX REGISTRY DEVICES IN THE RIIA AND REIA. REPORTEDLY THE VSX DEVICES REMAINED PATENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22386206 ↗
• 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), THE PATIENT EXPERIENCED A STEADY DECREASE IN PLATELET COUNT. THE PATIENT HAD A HIT POSITIVE TEST ON (B)(6) AND THE USE OF HEPARIN WAS DISCONTINUED. ADDITIONALLY, THE PATIENT HAD LEFT ARM SUPERFICIAL VENOUS THROMBOSIS, LEFT VENT

  Patient problems: Ischemia Stroke; Thrombocytopenia

  MAUDE report 20524480 ↗
• 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), THE PATIENT EXPERIENCED A STEADY DECREASE IN PLATELET COUNT. THE PATIENT HAD A HIT POSITIVE TEST ON (B)(6) AND THE USE OF HEPARIN WAS DISCONTINUED. ADDITIONALLY, THE PATIENT HAD LEFT ARM SUPERFICIAL VENOUS THROMBOSIS, LEFT VEN

  Patient problems: Ischemia Stroke; Thrombocytopenia

  MAUDE report 20524141 ↗
• InjuryApr 15, 2024Patient-Device Incompatibility; Patient-Device Incompatibility

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, TWO GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICES) WERE IMPLANTED TO REPAIR A POPLITEAL ANEURYSMS. IT WAS REPORTED ON AN UNKNOWN DATE AFTER THE IMPLANT PROCEDURE THROMBOSIS OF THE REPAIRED SITE WAS NOTED. REPORTEDLY, THE PHYSICIAN BELIEVES, DUE TO TIME OF ONSET AND AGGRESSIVENESS OF THROMBOSIS THAT THE PATIENT HAD HEPARIN INDUCED THROMBOCYTOPENIA (HIT). ADDITIONALLY, ON AN UNKNOWN DATE A REINTERVENTION OCCURRED (BYPASS REPAIR) IN WHICH BOTH VIABAHN DEVICES WERE EXPLANTED. AT AN UNKNOWN TIME SHORTLY AFTER THE BYPASS REPAIR THE SITE WAS THROMBOSED AS WELL. REPORTEDLY, ON AN UNKNOWN DATE AFTER PROCEDURE A PLATELET FACTOR 4 (PF4) TEST WAS COMPLETED WITH THE RESULT OF POSITIVE ANTIBODIES IN THE PATIENT. IT IS UNKNOWN WHAT TREATMENT THE PATIENT RECEIVED AFTER THE POSITIVE PF4, HOWEVER, THE PATIENT IS DOING WELL AND THE SYMPTOMS OF HIT HAVE RESOLVED.

  Patient problems: Thrombocytopenia; Thrombosis/Thrombus

  MAUDE report 19111896 ↗
• MalfunctionJun 15, 2022Separation Failure; Activation Failure; Separation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORT TO GORE: ON JUNE 8, 2022, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE LEFT SUBCLAVIAN ARTERY (PERISCOPE SANDWICH TECHNIQUE) DURING TREATMENT OF A TYPE B AORTIC DISSECTION. AFTER A COOK TX2 DEVICE WAS IMPLANTED IN THE DESCENDING AORTA. A VSX DEVICE WAS ADVANCED TO THE TREATMENT SITE OVER A 0.035" ROSEN WIRE THROUGH 8 FR DESTINATION SHEATH INTO12FR DRY SEAL SHEATH. HOWEVER, AFTER DEPLOYMENT WAS INITIATED, THE VSX DEVICE STARTED TO "BOWSTRING" AND STOPPED DEPLOYING. AFTER MULTIPLE ATTEMPTS TO CONTINUE DEPLOYMENT, THE PHYSICIAN ATTEMPTED TO REMOVE THE VSX DEVICE, DELIVERY CATHETER AND SHEATH IN TANDEM. AFTER MULTIPLE ATTEMPTS TO REMOVE THE VSX DEVICE, AND DEPLOYMENT SYSTEM, IT COULD NOT BE RETRIEVED. THE DECISION WAS MADE TO CUT THE DELIVERY CATHETER AND DEPLOYMENT LINE AT SKIN LEVEL AND LEAVE IT IN THE AORTA. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Pain

  MAUDE report 14703951 ↗