GORE VIABAHN Endoprosthesis with Heparin VBJR062502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00733132623976), received between Oct 9, 2018 and Jul 11, 2025 — classified as 4 injuries, 7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 11, 2025Complete Blockage; Complete Blockage

  ON AN UNKNOWN DATE, A PATIENT UNDERWENT TREATMENT FOR AN UNKNOWN DISEASE/ETIOLOGY IN AN UNKNOWN ANATOMICAL LOCATION USING MULTIPLE GORE® VIABAHN® DEVICES. ON (B)(6) 2025, PATIENT CONTACTED GORE'S CUSTOMER SERVICE LINE TO REPORT STENTS FAILING AND EXPRESSED INTEREST IN VOLUNTEERING TO BE PART OF A CLINICAL STUDY. THE PATIENT NOTED A HISTORY OF MULTIPLE BLOOD CLOTS IN LEGS AND CONVEYED FRUSTRATION DUE TO UNDERGOING IMPLANTATION OF OVER 41 GORE DEVICES. PATIENT IS REQUESTING TO SPEAK WITH SOMEONE REGARDING THIS MATTER. ON (B)(6) 2025, THE PATIENT PROVIDED ADDITIONAL INFORMATION RAISING CONCERNS ABOUT POTENTIAL CLOTTING IN THE RECENTLY IMPLANTED VIABAHN DEVICE IN THE RIGHT LEG, PLACED ON (B)(6) 2025. THIS CONCERN IS BASED ON ANGIOGRAM RESULTS FROM EARLY (B)(6) INDICATING TOTAL OCCLUSION IN THE RIGHT LEG. THE PATIENT IS SCHEDULED FOR A FOLLOW-UP APPOINTMENT WITH HIS PHYSICIAN ON (B)(6) 2025; HOWEVER, NO RE-INTERVENTION IS CURRENTLY PLANNED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 22476826 ↗
• MalfunctionNov 18, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) IN A HIGHLY CALCIFIED LEFT SUPERFICIAL FEMORAL ARTERY (SFA). IT WAS REPORTED THE PHYSICIAN ACCESSED THE PATIENT USING A 6F COOK INTRODUCER SHEATH OVER AN 0.014" COMMAND GUIDEWIRE TO THE TARGET TREATMENT SITE. IT WAS REPORTED THAT THERE WAS NO ISSUE ADVANCING THE INTRODUCER SHEATH. DURING DEPLOYMENT, THE DEPLOYMENT LINE WAS PULLED AND THERE WAS TENSION ON THE DEPLOYMENT STRING. THE PHYSICIAN DID NOT WANT TO GET INTO A SITUATION WHERE THEY HAD THE DEVICE PARTIALLY DEPLOYED; THEREFORE, THE DELIVERY CATHETER WAS WITHDRAWN. THE VIABAHN® DEVICE STENT GRAFT WAS NOT DEPLOYED, AND THE DELIVERY SYSTEM WAS REMOVED WITHOUT DIFFICULTY. THE LESION WAS PRE-DILATED AGAIN WITH A PTA BALLOON AND A NEW 6MM BY 15CM VIABAHN® DEVICE WAS UTILIZED OVER AN 0.018" GUIDEWIRE SUCCESSFULLY. IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20711147 ↗
• MalfunctionAug 25, 2022Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, THE PATIENT UNDERWENT A PROCEDURE TO TREAT A POPLITEAL ANEURYSM USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE GUIDEWIRE USED DURING THE PROCEDURE WAS A V-18. THE GUIDING SHEATH USED FOR THE PROCEDURE WAS A HALO ONE¿ THIN-WALLED GUIDING SHEATH 6FR. THE DEVICE WAS ADVANCED TO ITS INTENDED LOCATION WITH NO REPORTED ISSUE. THE DEPLOYMENT LINE OF THE DELIVERY CATHETER WAS PULLED FOR DEPLOYMENT OF THE STENT GRAFT. IT IS UNKNOWN IF THE DEPLOYMENT LINE BROKE DURING DEPLOYMENT. IT WAS REPORTED THE STENT GRAFT DID NOT FULLY EXPAND AT THE DISTAL END. AN ATTEMPT TO FULLY DEPLOYED THE DISTAL END OF THE STENT WAS MADE BY ADVANCING A 6 X 150MM ULTRAVERSE¿ PTA BALLOON ACROSS THE DISTAL PORTION OF THE DEVICE THAT WAS UNDEPLOYED. THE BALLOON WAS INFLATED, HOWEVER, THE STENT GRAFT REMAINED PARTIALLY EXPANDED. A SECOND ATTEMPT WAS MADE WITH A DORADO¿ PTA BALLOON DILATATION CATHETER 5 X 40MM BALLOON THAT WAS ALSO UNSUCCESSFUL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15294592 ↗
• InjuryApr 28, 2022Difficult to Remove; Difficult to Advance; Difficult to Remove; Difficult to Advance

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2022, A GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE WAS INTENDED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY FOR TREATMENT OF OCCLUSION. AFTER THE LESION WAS PRE-BALLOONED, THE PHYSICIAN ATTEMPTED TO ADVANCE THE VSX DEVICE OVER A 0.014" HI-TORQUE SPARTACORE, THROUGH A 6FR FLEXOR® ANSEL GUIDING SHEATH. HOWEVER, THE PHYSICIAN WAS UNABLE TO ADVANCE THE DEVICE THROUGH THE OCCLUDED LESION. AFTER MULTIPLE ATTEMPTS TO RETRACT THE VSX DEVICE, THE PHYSICIAN WAS UNABLE TO REMOVED THE DEVICE FROM THE OCCLUDED LESION. THE DECISION WAS MADE TO CUT THE DELIVERY CATHETER NEAR THE SKIN AND CONVERT THE PATIENT TO SURGICAL CONVERSION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Stenosis

  MAUDE report 14240860 ↗
• InjuryApr 2, 2020Activation Failure; Activation Failure

  IT WAS REPORTED TO GORE: ON (B)(6) 2020 A PATIENT UNDERWENT THE TREATMENT OF THE RIGHT SUPERFICIAL FEMORAL ARTERY OCCLUSION USING LEFT LEG ACCESS. A 6 MM X 25 CM GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN) WAS INTENDED TO BE PLACED IN THE FEMORAL ARTERY USING A 6FR SHEATH. OVER THE V18 WIRE THE PHYSICIAN BEGAN TO PULL THE DEPLOYMENT LINE AND 4 CM OF THE VIABAHN STARTED TO DEPLOY BEFORE THE PHYSICIAN COULD NO LONGER PULL THE DEPLOYMENT LINE. THE PHYSICIAN TRIED A LITTLE MORE PRESSURE WHILE PULLING BUT THE DEVICE WOULD NOT DEPLOY. THE PHYSICIAN HAD TO PULL THE DEVICE BACK TO THE SHEATH, HOWEVER THE VIABAHN WOULD NOT COLLAPSE BACK INTO THE SHEATH. EVERYTHING EXCEPT THE WIRE WAS PULLED BACK THROUGH THE ACCESS SITE. A NEW SHEATH WAS INSERTED ALONG WITH A NEW 6 MM X 25 CM GORE VIABAHN DEVICE AND WAS DEPLOYED WITH NO ISSUE. AS REPORTED, THERE WERE NO PRE-EXISTING DEVICES AT INTENDED TREATMENT SITE. MANUAL PRESSURE WAS HELD AT THE ACCESS SITE DURING THE PROCEDURE, HOWEVER THE PATIENT WAS BROUGHT BACK TO REPAIR A TEAR AND REMOVE PLAQUE AT THE ACCESS SITE THE NEXT DAY. THE PATIENT TOLERATED THE PROCEDURES AND IS DOING WELL.

  Patient problems: No Code Available

  MAUDE report 9917200 ↗
• MalfunctionNov 22, 2019Improper or Incorrect Procedure or Method; Activation Failure; Improper or Incorrect Procedure or Method; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE BY THE DOCTOR: THE PAD PATIENT PRESENTED FOR SFA REPAIR. THE GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED THROUGH A PREVIOUSLY DEPLOYED BARE METAL STENT. THE DEPLOYMENT LINE WAS PULLED AND APPROXIMATELY 1CM OF THE GORE® VIABAHN® ENDOPROSTHESIS DEPLOYED BUT DEPLOYMENT STOPPED. THE DOCTOR EXERTED GREAT TENSION ON THE DEPLOYMENT LINE WITH NO PROGRESS. AS THE DOCTOR CONTINUED TO PULL THE DEPLOYMENT LINE THE DEVICE APPEARED TO BOW. THE DOCTOR WAS ABLE TO WITHDRAW THE PARTIALLY DEPLOYED DEVICE INTO THE SHEATH AND REMOVED BOTH TOGETHER FROM THE PATIENT.

  Patient problems: Occlusion

  MAUDE report 9364054 ↗
• MalfunctionNov 12, 2019Material Separation; Material Separation

  THE FOLLOWING WAS REPORTED TO GORE BY THE HOSPITAL: THE PATIENT PRESENTED FOR A RIGHT LOWER EXTREMITY CASE. THE GORE® VIABAHN® ENDOPROSTHESIS SEPARATED FROM THE DELIVERY CATHETER PRIOR TO DEPLOYMENT.

  Patient problems: Occlusion

  MAUDE report 9313207 ↗
• InjuryJan 9, 2019Device Contamination with Body Fluid; Device Contamination with Body Fluid

  THE FOLLOWING WAS REPORTED TO GORE BY THE IMPLANTING SURGEON: THE PATIENT PRESENTED WITH STENOSIS IN THE SFA. A GORE® VIABAHN® ENDOPROSTHESIS WAS IMPLANTED (B)(6) 2018. THE PATIENT REPORTED PAIN (B)(6) 2018 IN THE AREA OF THE IMPLANT. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) ON (B)(6) 2018 REVEALED THE DEVICE WAS PERFORMING AS EXPECTED. ANOTHER CTA TAKEN (B)(6) 2018 REVEALED FLUID AROUND THE GORE® VIABAHN® ENDOPROSTHESIS. THE DEVICE WAS EXPLANTED (B)(6) 2018. THE DOCTOR REPORTED TO GORE THE FLUID AROUND THE DEVICE WAS CX POSITIVE FROM PERIVASCULAR FLUID STAPHYLOCOCCUS LUGDUNENSIS (COAGULASE-NEGATIVE, GRAM-POSITIVE BACTERIUM THAT CAN BE ISOLATED AS A COMPONENT OF NORMAL SKIN FLORA IN HUMANS).

  Patient problems: Stenosis

  MAUDE report 8231500 ↗
• MalfunctionDec 6, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT PRESENTED FOR TREATMENT IN THE SUPERFICIAL FEMORAL ARTERY DUE TO STENOTIC LESION. ATHERECTOMY WAS PERFORMED, AND A GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED AND DEPLOYED AT THE INTENDED TREATMENT SITE. AS REPORTED, THE DISTAL TIP BROKE OFF IN THE PATIENT AT SOME POINT. ANOTHER DEVICE (UNKNOWN MANUFACTURER) WAS DEPLOYED TO PIN THE DISTAL TIP AGAINST THE VESSEL WALL. MORE INFORMATION WAS REQUESTED BUT WAS NOT MADE AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8139794 ↗
• MalfunctionOct 10, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: PATIENT PRESENTED FOR FEMORAL ARTERY AND ANGIOPLASTY PROCEDURE DUE TO PROGRESSING SUPERFICIAL FEMORAL ARTERY DISEASE. ACCESS WAS GAINED FROM THE CONTRALATERAL LEG. A 6FR COOK SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® ENDOPROSTHESIS OVER A SVS CORDIS GUIDEWIRE. THE VIABAHN DEVICE REACHED THE INTENDED TREATMENT SITE AND WAS DEPLOYED WITH NO ISSUES. AS THE CATHETER WAS BEING WITHDRAWN, THE CATHETER WAS PULLED WITH FORCE BECAUSE STRONG RESISTANCE WAS ENCOUNTERED. THE CATHETER BROKE AND TWO-THIRDS OF IT WAS REMOVED. NEXT, THE SHEATH REST OF THE CATHETER WERE REMOVED TOGETHER. IT WAS REALIZED THE DISTAL TIP OF THE CATHETER HAD GOTTEN HUNG UP ON THE EDGE OF THE SHEATH WHEN CATHETER APPEARED TO BE STUCK. A NEW SHEATH WAS PLACED AND ADDITIONAL DEVICES WERE PLACED TO COMPLETE THE PROCEDURE WITH NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7954780 ↗
• MalfunctionOct 9, 2018Premature Separation; Premature Separation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2018, A PATIENT WAS UNDERGOING OF A SUPERFICIAL FEMORAL ARTERY OCCLUSION WITH A GORE® VIABAHN® ENDOPROSTHESIS. THE LESION WAS PREDILATED. THE DEVICE WAS BEING ADVANCED OVER A V18 WIRE THROUGH A 6FR PINNACLE SHEATH. AT SOME POINT THE DEVICE SEPARATED FROM THE DELIVERY SYSTEM. NO DEVICE EXPANSION HAD OCCURRED. THE DEVICE AND SHEATH WERE REMOVED AS A UNIT. WIRE ACCESS WAS LOST. THE CASE WAS COMPLETED WITH TWO NEW VIABAHN DEVICES. THE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7948521 ↗