GORE VIABAHN Endoprosthesis with Heparin VBJR050502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00733132623907), received between Aug 29, 2018 and Mar 30, 2026 — classified as 2 injuries, 5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Break; Activation Failure

  ON (B)(6) 2026, THE PATIENT UNDERWENT A TRANSCAROTID ARTERY REVASCULARIZATION (TCAR) PROCEDURE TO TREAT A CAROTID ARTERY ANEURYSM, DURING WHICH A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED TO BE IMPLANTED. THE PHYSICIAN PERFORMED A CUT DOWN IN THE CAROTID WITH THE SILK ROAD SYSTEM. THE VIABAHN DEVICE REACHED THE TARGET TREATMENT AREA GOING THROUGH AN 8FR INTRODUCER SHEATH (UNSPECIFIED MANUFACTURE) AND, OVER 0.018" GUIDEWIRE. THE PHYSICIAN BEGAN A SLOW DEPLOYMENT OF THE VIABAHN DEVICE WITH THE INTENT OF ANCHORING THE DISTAL PORTION IN THE INTERNAL CAROTID ARTERY. HOWEVER, DUE TO THE INTERACTION BETWEEN THE GUIDEWIRE AND THE SLOW DEPLOYMENT WITHIN THE ANEURYSMAL SEGMENT, THE DEVICE DID NOT DEPLOY PROPERLY. APPROXIMATELY FOUR-FIFTHS OF THE VIABAHN ENDOPROSTHESIS DEPLOYED. THE PHYSICIAN ATTEMPTED TO FORCE COMPLETION BY PULLING MORE FIRMLY ON THE DEPLOYMENT LINE. THIS ACTION RESULTED IN THE DEPLOYMENT LINE BREAKING. TO RETRIEVE THE VIABAHN DEVICE, THE PHYSICIAN EXTENDED THE CAROTID ARTERIOTOMY AND ADVANCED THE PARTIALLY DEPLOYED DEVICE, WITH THE OLIVE TIP, INTO THE 8 FR SHEATH, ALLOWING BOTH THE VIABAHN DEVICE AND THE SHEATH TO BE WITHDRAW

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24732448 ↗
• MalfunctionDec 26, 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 PERIPHERAL ARTERY DISEASE. IT WAS REPORTED THAT AFTER THE DEVICE WAS ADVANCED ACROSS THE LESION THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE. HOWEVER, AFTER THE PHYSICIAN INITIATED DEPLOYMENT, THE DEPLOYMENT LINE WOULD NOT RELEASE THE VSX DEVICE. 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 21021188 ↗
• MalfunctionDec 26, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR A POPLITEAL ATHEROSCLEROTIC IN THE POPLITEAL ARTERY UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE). IT WAS REPORTED THAT THE VIABAHN® DEVICE DID NOT DEPLOY. REPORTEDLY, THE TARGET LESION WAS PRE-DILATED. THE PHYSICIAN SUSPECTS THE STRING BROKE UPON DEPLOYMENT. A 6FR X 45CM TERUMO DESTINATION SHEATH WAS USED AND A 0.035" STIFF GLIDE WIRE. ANOTHER VIABAHN® DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO IMPACT/HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019998 ↗
• InjuryDec 26, 2024Detachment of Device or Device Component; Activation Failure; Detachment of Device or Device Component; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT A PERCUTANEOUS DEEP VENOUS ARTERIALIZATION (PDVA) PROCEDURE WHERE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (GORE® VIABAHN® DEVICE) DEVICES WERE USED IN AN ARTERIOVENOUS FISTULA (AVF) CREATION IN AN ATTEMPT TO SALVAGE THE LEFT LEG. IT WAS REPORTED THE PHYSICIAN ACCESSED THE POSTERIOR TIBIAL ARTERY VIA GROIN ACCESS, AND THE TIBIAL VEIN VIA PEDAL ACCESS USING A 6F SLENDER INTRODUCER SHEATH OVER A V-18¿ CONTROLWIRE¿ GUIDEWIRE. IT WAS REPORTED DURING THE LINING OF THE VEIN WITH GORE® VIABAHN® DEVICES, A VERY TIGHT DISTAL VEIN VALVE WAS NOTICED NEAR THE FOOT. THE PHYSICIAN PERFORMED BALLOON ANGIOPLASTY, AND THEN ADVANCED A 5 MM X 5 CM GORE® VIABAHN® DEVICE IN THE TREATMENT AREA. REPORTEDLY, DURING DEPLOYMENT, THE LINE WAS PULLED AND THE ENDS OF THE ENDOPROSTHESIS DEPLOYED, BUT THE MIDDLE SECTION REMAINED CONSTRAINED. AN ATTEMPT WAS MADE TO WITHDRAW THE DELIVERY CATHETER, BUT IT WAS UNSUCCESSFUL. A SURGICAL CUTDOWN WAS PERFORMED ON THE FOOT AND THE CATHETER AND ENDOPROSTHESIS WERE REMOVED. HOWEVER, THE DISTAL TIP OF THE DELIVERY CATHETER COULD NOT BE LOCATED. THE PROCEDURE WAS CONTINUED AND COMPLETED USING A 5 MM X 10 CM GORE® VIABAH

  Patient problems: Insufficient Information

  MAUDE report 21019580 ↗
• MalfunctionNov 18, 2020Detachment of Device or Device Component; Device Damaged by Another Device; Detachment of Device or Device Component; Device Damaged by Another Device

  THE FOLLOWING WAS REPORTED TO GORE: THE PHYSICIAN HAD LEFT COMMON FEMORAL ARTERY(CFA) ACCESS AND WANTED TO GO UP AND OVER TO THE RIGHT TO TREAT THE EXTERNAL ILIAC ARTERY. THE PHYSICIAN ATTEMPTED TO BAREBACK A 5X5CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE(VSX) UP AND OVER THE BIFURCATION THROUGH A SHORT 6FR X 10CM PINNACLE SHEATH ON A V-18 WIRE. IT WAS OBSERVED THAT ON THE RIGHT SIDE WAS A RIGHT COMMON ILIAC STENT RIGHT AT THE AORTIC BIFURCATION. THE VIABAHN STENT BECAME STUCK ON THE OLD RIGHT COMMON ILIAC STENT AND WHEN THE PHYSICIAN ATTEMPTED TO APPLY MORE PRESSURE THE VIABAHN STENT CATHETER APPEARED TO EITHER GET KINKED OR STUCK ON THE WIRE. ATTEMPTS WERE MADE TO REMOVE THE DEVICE, AND WERE UNSUCCESSFUL. AT SOME POINT THE STENT CATHETER FRACTURED AND THE STENT PORTION ALONG WITH THE DEPLOYMENT STRING SEPARATED FROM THE REST OF THE CATHETER. AT THIS POINT THE PHYSICIAN GAINED RIGHT CFA ACCESS AND INSERTED AN 8FR SHEATH TO ATTEMPT RETRIEVAL. A 10MM ENSNARE WAS USED TO CAPTURE THE STENT. THE STENT WOULD NOT TRACK THROUGH THE 8FR SHEATH SO THE DOCTOR PULLED THE SHEATH AND STENT OUT IN TANDEM. REMOVAL WAS SUCCESSFUL. THE PHYSICIAN DECIDED TO INSERT ANOTHER VIABAHN

  Patient problems: Intimal Dissection

  MAUDE report 10864641 ↗
• MalfunctionAug 25, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, THE PATIENT WAS BEING TREATED FOR A STENOTIC LESION IN THE PATIENT¿S SUPERFICIAL FEMORAL ARTERY USING TWO GORE® VIABAHN® ENDOPROSTHESES. THE FIRST VIABAHN WAS ADVANCED AND IMPLANTED WITH NO ISSUE. THE SECOND VIABAHN WAS ADVANCED AND IMPLANTED SUCCESSFULLY FOR DISTAL EXTENSION. HOWEVER, AS THE VIABAHN WAS BEING WITHDRAWN FROM THE PATIENT THE TIP OF THE CATHETER REPORTEDLY SEPARATED FROM THE CATHETER. THE PHYSICIAN STATED IT IS UNKNOWN WHAT CAUSED THE SEPARATION OF THE CATHETER TIP. THE TIP WAS STILL ON THE WIRE AND WAS GRABBED AND REMOVED FROM THE PATIENT¿S BODY WITH A SNARE DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10451372 ↗
• MalfunctionAug 29, 2018Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018 A PATIENT WAS UNDERGOING TREATMENT OF A SPLENIC ARTERY ANEURYSM WITH A GORE® VIABAHN® ENDOPROSTHESIS. THE DEVICE WAS ADVANCED OVER A .018" V18 WIRE THROUGH A 6FR TERUMO SHEATH, TO THE DESIRED LOCATION. DEPLOYMENT WAS INITIATED, HOWEVER ABOUT HALFWAY THROUGH DEPLOYMENT, THE DEPLOYMENT LINE BROKE, LEAVING HALF OF THE DEVICE REMAINING CONSTRAINED ON THE DELIVERY CATHETER. THE DEVICE WAS THEN PULLED BACK THROUGH THE BRACHIAL ACCESS. THE CASE WAS FINISHED BY USING COILS TO EMBOLIZE THE ANEURYSM. THE CASE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7826895 ↗