GORE VIABAHN Endoprosthesis with Heparin VBJR071002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00733132623778), received between Jul 24, 2018 and Mar 2, 2026 — classified as 2 injuries, 7 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.

• MalfunctionMar 2, 2026Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2026, THE PATIENT UNDERWENT TREATMENT FOR AN ANEURYSM WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED TO BE IMPLANTED IN THE POPLITEAL ARTERY. AFTER REACHING THE TARGET TREATMENT AREA, DEPLOYMENT OF THE VIABAHN DEVICE WAS INITIATED BY PULLING ON THE DEPLOYMENT LINE, HOWEVER, THE DEPLOYMENT LINE BECAME UNEXPECTEDLY STUCK FOR REASONS THAT REMAIN UNKNOWN. THE PHYSICIAN DISCONTINUED DEPLOYMENT AS EACH ATTEMPT CAUSED THE DELIVERY CATHETER TO SHIFT FROM ITS PROPER INTRAVASCULAR POSITION. THE DELIVERY CATHETER, WITH THE VIABAHN ENDOPROSTHESIS STILL UNDEPLOYED, WAS WITHDRAWN THROUGH THE SHEATH OUT OF THE PATIENT. THE PHYSICIAN THEN IRRIGATED, AND REINTRODUCED THE SAME VIABAHN DEVICE TO ITS ORIGINAL POSITION. WHEN THE PHYSICIAN RE-APPLIED GREATER FORCE TO PULL ON THE DEPLOYMENT LINE, RESULTING IN THE DEPLOYMENT LINE BRAKING, AND THE VIABAHN DEVICE DID NOT DEPLOY. THE VIABAHN DEVICE WAS SUBSEQUENTLY WITHDRAWN, AND A NEW VIABAHN DEVICE WAS UTILIZED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THERE WAS NO PATIENT HARM. THERE WAS NO BOW STRINGING NOR TORTUOUS ANATOMY OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24491690 ↗
• MalfunctionDec 22, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, THE PATIENT UNDERWENT A TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE, DURING WHICH BLEEDING WAS OBSERVED IN THE ILIAC ARTERY. TO ADDRESS THIS COMPLICATION, THE PHYSICIAN INTENDED TO IMPLANT A 7X10 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) IN THE ILIAC ARTERY. DURING THE INTERVENTION, A 7FR TERUMO DESTINATION¿ GUIDING SHEATH AND A 0.014" BALANCE MIDDLEWEIGHT UNIVERSAL (BMW) GUIDEWIRE WERE UTILIZED TO ACCESS THE TARGET TREATMENT AREA. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE VIABAHN DEVICE BY PULLING THE DEPLOYMENT LINE, IT FAILED TO DEPLOY. THE DEVICE WAS SUBSEQUENTLY WITHDRAWN, AND THE PROCEDURE WAS COMPLETED USING A 7X29 GORE®VIABAHN®VBX BALLOON EXPANDABLE ENDOPROSTHESIS. THE PHYSICIAN WAS UNABLE TO DETERMINE THE CAUSE OF THE DEPLOYMENT FAILURE. THE FIELD SALES ASSOCIATE ADVISED THAT AN 0.018" GUIDEWIRE WOULD HAVE BEEN MORE APPROPRIATE THAN THE 0.014" GUIDEWIRE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871985 ↗
• MalfunctionAug 12, 2025Break; Failure to Advance; Separation Failure; Malposition of Device; Break; Failure to Advance; Separation Failure; Malposition of Device

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR A IN-STENT RESTENOSIS OF A BARE METAL STENT (MANUFACTURE UNKNOWN) WHICH WAS PLACED IN THE LEFT COMMON ILIAC (LCI) EXTENDING TO THE EXTERNAL ILIAC. A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS IMPLANTED IN THE SUPERFICIAL FEMORAL ARTERY (SFA) WITH LEFT FOOT ACCESS. THE VIABAHN DEVICE WAS INTENDED TO BE IMPLANTED IN THE LEFT COMMON ILIAC ARTERY. A 6-7FR TERUMO GLIDESHEATH SLENDER® HYDROPHILIC COATED INTRODUCER SHEATH WAS USED ALONG WITH A .018 ASAHI GLADIUS® GUIDEWIRE. THE TARGET TREATMENT AREA WAS NOT PRE-DILATED AND THE PHYSICIAN WENT IN WITH INTRAVASCULAR ULTRASOUND (IVUS). JUST BELOW THE KNEE OR AT THE KNEE APPEARED WIDE OPEN, NO TORTUOUS ANATOMY OR CALCIFICATION. ONCE THE SFA WAS REACHED THE PHYSICIAN COULD NO LONGER ADVANCE OR RETRACT THE VIABAHN DEVICE DUE TO AN UNKNOWN BLOCKAGE, THE PHYSICIAN MADE A DECISION TO DEPLOY THE VIABAHN DEVICE IN THE SFA BY PULLING ON THE DEPLOYMENT LINE WITH NO RESISTANCE, HOWEVER, THE DEPLOYMENT LINE BROKE AND THE PHYSICIAN WAS UNSURE IF VIABAHN DEVICE DEPLOYED OR REMAINED CONSTRAINED SINCE A SIGNIFICANT AMOUNT OF DEPLOYMENT LINE WAS PULLED, THERE WAS NO DIS

  Patient problems: Vascular Dissection

  MAUDE report 22785929 ↗
• MalfunctionJul 24, 2025Activation Failure; Physical Resistance/Sticking; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2025, THE PATIENT UNDERWENT TREATMENT FOR STENOSIS IN THE EXTERNAL ILIAC ARTERY WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS USED. ACCESS TO THE TARGET TREATMENT AREA WAS ACHIEVED USING A 7FR TERUMO PINNACLE® INTRODUCER SHEATH AND A 0.018" GUIDEWIRE (BRAND UNSPECIFIED), WITHOUT COMPLICATIONS. UPON INITIATING DEPLOYMENT, THE PHYSICIAN ENCOUNTERED RESISTANCE WHEN ATTEMPTING TO PULL THE DEPLOYMENT LINE, WHICH BECAME STUCK. AS A RESULT, ONLY 1 CM OF THE VIABAHN DEVICE'S DISTAL END WAS ABLE TO EXPAND. THE DEVICE WAS SUBSEQUENTLY WITHDRAWN IN TANDEM WITH THE INTRODUCER SHEATH. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT VIABAHN DEVICE. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT. ACCORDING TO THE REPORT, NO EXCESSIVE FORCE WAS APPLIED DURING DEPLOYMENT NOR WERE THEY PULLING THE DEPLOYMENT LINE TOO FAST. THE PHYSICIAN NOTED THE PRESENCE OF CALCIFICATION AT THE TARGET TREATMENT AREA AND REMAINS UNCERTAIN REGARDING THE UNDERLYING CAUSE OF THE DEPLOYMENT LINE BEING STUCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22588326 ↗
• MalfunctionNov 15, 2024Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT UNDERWENT TREATMENT OF AN AV FISTULA THAT PRESENTED WITH STENOSIS WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED TO BE IMPLANTED. THE PHYSICIAN WAS ABLE TO REACH THE TARGET TREATMENT AREA WITH NO RESISTANCE USING A 7 FR TERUMO INTRODUCER SHEATH AND A TERUMO GLIDEWIRE ADVANTAGE® GUIDEWIRE. HOWEVER, WHEN THEY WENT TO DEPLOY THE VIABAHN DEVICE IT FAILED DEPLOYMENT AS THERE WAS RESISTANCE WHEN PULLING THE DEPLOYMENT LINE. RESISTANCE WAS MET AROUND 3-4 CM OF PULLING THE DEPLOYMENT LINE. SOME FORCE WAS ATTEMPTED WHILE PULLING THE DEPLOYMENT LINE BUT STILL HAD AN UNSUCCESSFUL DEPLOYMENT. SOME BOW STRINGING WAS NOTICED. THE PHYSICIAN REMOVED THE VIABAHN DEVICE FROM THE PATIENT THROUGH THE SHEATH AND COMPLETED THE PROCEDURE USING A NEW VIABAHN DEVICE. AFTER EXAMINING THE VIABAHN DEVICE, IT WAS NOTICED THE CATHETER AND STENT WERE STILL INTACT. THERE WAS NO DEVICE EXPANSION. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT. PLEASE NOTE, THE RETURNED DEVICE WAS EXPANDED ON THE BACK TABLE AFTER USE AND NOT INSIDE OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20695350 ↗
• MalfunctionJul 1, 2024Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A 7 MM X 10 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS USED IN THE LEFT EXTERNAL ILIAC ARTERY FOR AN OCCLUSIVE VESSEL. THE VIABAHN® DEVICE WAS ADVANCED OVER A 0.014¿ COMMAND GUIDEWIRE THROUGH A 7 F COOK INTRODUCER SHEATH WITHOUT DIFFICULTY. THE TARGET TREATMENT SITE WAS REACHED WHEN, REPORTEDLY, THE DEPLOYMENT LINE WAS STUCK AFTER PULLING IT APPROXIMATELY HALF WAY WITH NORMAL FORCE. THE PHYSICIAN THEN CUT THE HUB OF THE CATHETER OFF INTENTIONALLY TO ATTEMPT TO PULL THE DEPLOYMENT LINE ALL THE WAY WITHOUT SUCCESS. THE VIABAHN® DEVICE DELIVERY CATHETER WAS REMOVED WITHOUT DIFFICULTY AND THE PARTIALLY EXPANDED VIABAHN® DEVICE STENT GRAFT WAS LEFT IN THE PATIENT. THE VIABAHN® DEVICE STENT GRAFT WAS ABLE TO BE SUCCESSFULLY IMPLANTED WITH A PTA BALLOON WITHOUT AN ISSUE. THE PROCEDURE WAS SUCCESSFUL AND THERE WERE NO CONSEQUENCES OR IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644220 ↗
• InjurySep 6, 2018Complete Blockage; Off-Label Use; Complete Blockage; Off-Label Use

  IT WAS REPORTED TO GORE THAT ON (B)(6) 2018, A PATIENT WAS TREATED FOR A LEFT LEG POPLITEAL ARTERY ANEURYSM USING TWO GORE® VIABAHN® ENDOPROSTHESES WITH HEPARIN BIOACTIVE SURFACE. THE PATIENT REPORTED HIS LEG FELT BETTER FOR A PERIOD OF TIME AFTER THE (B)(6) PROCEDURE, BUT HIS LEG DID NOT IMPROVE AS HE HAD HOPED. IT WAS REPORTED THE SWELLING IN THE PATIENT¿S LEFT LEG DID NOT DECREASE, AND HE EXPERIENCED A FAIR AMOUNT OF DISCOMFORT THAT VARIED DAY BY DAY. THE PATIENT REPORTED THAT ON (B)(6) 2018, HE PRESENTED TO HIS LOCAL EMERGENCY ROOM WITH LEG DISCOLORATION, INTENSE CRAMPING, AND PAIN IN HIS LEFT LEG, AND IT WAS REPORTEDLY DETERMINED THERE WAS NO CIRCULATION BELOW THE PATIENT¿S LEFT KNEE. IT WAS FURTHER REPORTED THAT IMAGING SHOWED THE TWO GORE® VIABAHN® ENDOPROSTHESES WERE OCCLUDED. ACCORDING TO THE REPORT, THE HOSPITAL EMERGENTLY TRANSFERRED THE PATIENT VIA AIR EVACUATION TO (B)(6), WHERE THE PATIENT WAS ADMITTED FOR TREATMENT OF THE OCCLUSION. IT WAS REPORTED TO THE PATIENT THAT A RADIOLOGIST ATTENDING TO THE PATIENT DURING HIS (B)(6) 2018 VISIT STATED HIS STENTS DID NOT OCCLUDE ALL AT ONCE, AND THAT THE OCCLUSION WAS A GRADUAL PROCESS. IT WAS REPORTED THAT ON (B)(6) 2018, THE

  Patient problems: Cramp(s); Ischemia; Numbness; Pain; Skin Discoloration

  MAUDE report 7854005 ↗
• MalfunctionSep 5, 2018Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR SFA OCCLUSION REPAIR. THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN WAS ADVANCED INTO PLACE AND THE DEPLOYMENT LINE PULLED. ACCORDING TO THE DOCTOR, WHILE PULLING THE DEPLOYMENT LINE, THE DEPLOYMENT LINE AND DEPLOYMENT STOPPED AFTER APPROXIMATELY 1CM OF EXPANSION. THE DEVICE WAS PULLED BACK INTO THE SHEATH AND REMOVED FROM THE PATIENT. THE DOCTOR REPORTED THE DEVICE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: Occlusion

  MAUDE report 7846185 ↗
• InjuryJul 24, 2018Adverse 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) 2016, THE PATIENT UNDERWENT TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM WHEREBY CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESES AND GORE® VIABAHN® ENDOPROSTHESES WITH HEPARIN BIOACTIVE SURFACE WERE IMPLANTED. ON (B)(6) 2018 THE PATIENT EXHIBITED A GUTTER LEAK AROUND THE LEFT RENAL ARTERY. ON (B)(6) 2018 THE PATIENT'S LEFT RENAL ARTERY WAS STENTED AND A LEFT RENAL ARTERY BRANCH IN THE GUTTER SPACE WAS EMBOLIZED. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Aneurysm

  MAUDE report 7715982 ↗