GORE VIABAHN Endoprosthesis with Heparin VBJR060502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132623952), received between Oct 4, 2018 and Jan 15, 2026 — classified as 1 injury, 8 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 15, 2026Activation Failure; Physical Resistance/Sticking

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR CLAUDICATION IN PERIPHERAL VASCULAR DISEASE. THE PROCEDURE PERFORMED WAS A LEFT LOWER EXTREMITY ANGIOGRAM WITH INTERVENTION UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. DURING THE PROCEDURE, THE DELIVERY SYSTEM CATHETER ADVANCED THROUGH AN UNKNOWN SIZE/BRAND INTRODUCER SHEATH OVER AN UNSPECIFIED SIZE/BRAND GUIDEWIRE TO THE TARGET TREATMENT SITE. THE EXACT ANATOMICAL LOCATION BEING TREATED WAS NOT PROVIDED. IT IS UNKNOWN IF THE TARGET LESION WAS PRE-DILATED. THE DELIVERY CATHETER REACHED THE INTENDED TREATMENT SITE. DURING DEPLOYMENT, THE DEPLOYMENT LINE WAS PULLED, BUT PRIOR TO THE COMPLETION OF DEPLOYMENT, THE LINE BECAME STUCK. SEVERAL ATTEMPTS TO CONTINUE DEPLOYMENT WERE MADE BUT WERE UNSUCCESSFUL. THE DEPLOYMENT LINE COULD BE VISUALIZED AT THE LOCATION OF THE STENT AND WAS PUTTING ENOUGH TENSION ON THE STENT AND CATHETER TO CURVE THE END OF THE CATHETER SLIGHTLY. THE DELIVERY CATHETER WAS WITHDRAWN FROM THE PATIENT OVER THE WIRE, AND WAS REPORTEDLY INTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24082051 ↗
• MalfunctionSep 15, 2025Activation Failure; Activation Failure

  ON (B)(6)2025, A PATIENT UNDERWENT TREATMENT FOR A PERIPHERAL ARTERY DISEASE (PAD) IN THE SUPERFICIAL FEMORAL ARTERY (SFA) USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE). IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A 6MM X 5.0CM VIABAHN DEVICE OVER A TERUMO 0.018" GUIDEWIRE THROUGH A BOSTON 6FR INTRODUCER SHEATH. AS THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE DEVICE, IT WAS NOTED THAT THE DEPLOYMENT LINE BROKE. REPORTEDLY, NO CALCIFICATION WAS NOTED, AND THE TARGET TREATMENT AREA HAD BEEN SUCCESSFULLY REACHED PRIOR TO DEPLOYMENT. THE PHYSICIAN DID NOT APPLY EXCESSIVE FORCE AND WAS ABLE TO PULL APPROXIMATELY 5¿10 CM BEFORE THE LINE BROKE. NO DISTAL EXPANSION OR STENT OPENING WAS OBSERVED. THE DEVICE WAS WITHDRAWN FROM THE PATIENT AND NO FRAGMENT WAS LEFT WITHIN THE PATIENT. THE PHYSICIAN ATTRIBUTED THE FAILURE TO THE DEPLOYMENT LINE BREAKING, WHICH PREVENTED THE DEVICE FROM DEPLOYING. A NEW GORE 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 23059625 ↗
• MalfunctionJun 2, 2025Break; Activation Failure; Break; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR AN UNKNOWN ETIOLOGY IN AN UNKNOWN ANATOMICAL LOCATION USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE). IT WAS REPORTED DURING A PROCEDURE, THE PHYSICIAN-INITIATED DEPLOYMENT BY PULLING THE DEPLOYMENT LINE, AS THE PHYSICIAN PULLED THE DEPLOYMENT LINE AROUND 1.5 INCHES, THE DEPLOYMENT LINE BROKE. REPORTEDLY, THE PHYSICIAN REMOVED THE VIABAHN DEVICE AND USED A NEW ONE TO SUCCESSFULLY COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124064 ↗
• InjuryApr 4, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, THE PATIENT UNDERWENT A PROCEDURE FOR PERIPHERAL ARTERIAL DISEASE (PAD) IN THE SUPERFICIAL FEMORAL ARTERY (SFA) AND POPLITEAL ARTERY USING BARE METAL STENTS (BMS). A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS USED DURING THE PROCEDURE TO TREAT AN IATROGENIC INJURY. IT WAS REPORTED; THE PHYSICIAN ACCESSED THE PATIENT CONTRALATERALLY USING A 6F TERUMO DESTINATION GUIDING SHEATH OVER A .018" V-18 CONTROLWIRE GUIDEWIRE. REPORTEDLY, DURING THE PROCEDURE BMS DEVICES WERE IMPLANTED. DURING FINAL IMAGING, AN EXTRAVASATION (SMALL BLEED) NEAR THE END OF THE BMS IN THE POPLITEAL ARTERY, WAS SEEN ON IMAGING. IT WAS SUSPECTED A WIRE GOT CAUGHT ON THE BMS, CAUSING A MICRO-PERFORATION. REPORTEDLY, THE DECISION WAS MADE TO USE A 6 MM X 5 CM VIABAHN DEVICE TO TREAT THE BLEED. THE DELIVERY SYSTEM WAS ADVANCED TO THE TARGET TREATMENT SITE. THE DEPLOYMENT LINE WAS PULLED, AND THE PROXIMAL PORTION OF THE ENDOPROSTHESIS EXPANDED, BUT THE DISTAL END REMAINED CONSTRAINED. IT IS UNKNOWN IF THE DEPLOYMENT LINE BROKE. IT WAS REPORTED, THE PHYSICIAN WAS GOING TO WITHDRAW THE DELIVERY SYSTEM CATHETER, AND THEN ADVANCE ANOTHER BALLOON TO EXPAND THE DEVICE F

  Patient problems: Insufficient Information

  MAUDE report 21775835 ↗
• MalfunctionDec 30, 2024Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY DURING TREATMENT OF A PREEXISTING DISSECTION. IT WAS REPORTED THAT AFTER THE DEVICE WAS ADVANCED ACROSS THE LESION THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE. HOWEVER, AFTER THE PHYSICIAN UNSCREWED THE DEPLOYMENT KNOB, HE WAS UNABLE TO PULL THE DEPLOYMENT LINE. WITH NO DEVICE EXPANSION, THE VSX DEVICE WAS REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH AN ADDITIONAL VSX DEVICE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21044469 ↗
• MalfunctionOct 23, 2024Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR AN ANEURYSM WHERE A 6 MM X 5 CM GORE® VIABAHN® ENDOPROSTHESIS (GORE® VIABAHN® DEVICE) WAS INTENDED TO BE USED IN THE SPLENIC ARTERY. IT WAS REPORTED THE PHYSICIAN ADVANCED THE DELIVERY CATHETER THROUGH EXTREMELY TORTUOUS ANATOMY USING A 6.5F DESTINO STEERABLE SHEATH OVER AN UNKNOWN SIZE PLATINUM PLUS GUIDEWIRE TO THE TARGET TREATMENT ZONE. IT WAS REPORTED THE DELIVERY CATHETER WAS ADVANCED WITHOUT RESISTANCE. REPORTEDLY, DURING DEPLOYMENT, THE LINE WAS PULLED AND BECAME STUCK. THE TIP OF THE CATHETER WAS MOVING TOO MUCH DUE TO THE TUGGING OF THE LINE, AND DEPLOYMENT WAS ABORTED. THE PHYSICIAN WITHDREW THE CATHETER, WITH THE ENDOPROSTHESIS FULLY CONSTRAINED. IT WAS REPORTED THE DEPLOYMENT LINE DID NOT BREAK. THE PHYSICIAN SUSPECTS THE TORTUOSITY MADE IT DIFFICULT TO DEPLOY THE ENDOPROSTHESIS. THE PROCEDURE WAS COMPLETED USING A DIFFERENT 6 MM X 5 CM GORE®VIABAHN® DEVICE. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517800 ↗
• MalfunctionNov 17, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THE FOLLOWING WAS REPORTED TO GORE: ON OCTOBER THE PATIENT PRESENTED FOR SFA OCCLUSIVE DISEASE. DURING THE PROCEDURE A GORE® VIABAHN® ENDOPROSTHESIS SNAGGED ON A PREVIOUSLY PLACED STENT (BRAND UNKNOWN) AND BEGAN TO PARTIALLY PRE-DEPLOY. THE DEVICE WAS REMOVED FROM THE PATIENT. ANOTHER GORE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10857073 ↗
• MalfunctionJul 1, 2019Failure to Unfold or Unwrap; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Failure to Unfold or Unwrap; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR AORTIC ANEURYSM REPAIR. THE GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN) WAS INTENDED TO BE USED AS A SNORKEL DEVICE IN THE RENAL ARTERY FROM A BRACHIAL APPROACH. A 7FR DESTINATION SHEATH AND TWO .014 SPARTECORE WIRES WERE PLACED IN THE RIGHT AND LEFT RENALS. A 28 MM ENDURANT GRAFT, GROIN ACCESS, WAS PLACED IN THE AORTA. THE VIABAHN WAS ADVANCED INTO PLACE, IN THE RENAL, AND THE DEPLOYMENT LINE WAS PULLED. THE DEVICE PARTIALLY OPENED THEN THE DEPLOYMENT LINE FRAYED AND BROKE. ATTEMPTS WERE MADE TO ACCESS THE REMAINING DEPLOYMENT LINE WITHOUT SUCCESS. THE DOCTOR DECIDED TO REMOVE THE PARTIALLY DEPLOYED VIABAHN FROM THE PATIENT. WHEN THE VIABAHN WAS REMOVED IT WAS OBSERVED THE 28 MM ENDURANT GRAFT COVERED THE RENALS. HOWEVER, ACCORDING TO THE DOCTOR, THE RENALS WERE GETTING BLOOD FROM SOMEWHERE. ACCORDING TO THE DOCTOR, THE PATIENT WAS DOING WELL AFTER THE PROCEDURE WAS COMPLETED.

  Patient problems: Aneurysm

  MAUDE report 8749699 ↗
• MalfunctionOct 4, 2018Leak/Splash; Activation, Positioning or Separation Problem

  PROCEDURAL NOTES: "THE LEFT FEMORAL ARTERY WAS CANNULATED. GUIDEWIRE WAS INSERTED. OVER THE GUIDEWIRE, A 6-FRENCH SHEATH WAS ADVANCED. AT THIS TIME, A RETROGRADE ILIAC ARTERIOGRAM WAS PERFORMED VISUALIZING THE AREA OF THE BLUSH LEAKING FROM THE DISTAL EXTERNAL ILIAC ARTERY. AT THIS TIME, A 6X5 VIABAHN COVERED STENT WAS INSERTED OVER THE WIRE. IT DID NOT DEPLOY CORRECTLY. AS SUCH, THE SHEATH WAS REMOVED, A NEW 6-FRENCH SHEATH WAS ADVANCED AND A 6X5 VIABAHN STENT WAS THEN INSERTED IN THE AREA OF THE LEAK, COVERING IT. A REPEAT ARTERIOGRAM REVEALED PERSISTENT LEAK. AS SUCH, A SECOND STENT COVERING A LITTLE FURTHER DISTALLY, JUST TO AND ABOVE THE FEMORAL HEAD, WAS PLACED AND THEN INFLATED AND POSITIONED. REPEAT RETROGRADE ILIAC ARTERIOGRAM REVEALED NO FURTHER LEAKING OR BLEEDING."

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 7933613 ↗