GORE VIABAHN Endoprosthesis with Heparin VBHR090502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00733132645947), received between Sep 14, 2021 and May 15, 2026 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Difficult or Delayed Activation

  ON (B)(6) 2026, THE PATIENT UNDERWENT TAMBE ENDOVASCULAR TREATMENT FOR AN ARTERIAL DISSECTION UTILIZING MULTIPLE GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX DEVICE) DEVICES IN THE VISCERAL VESSELS AND A GORE® TRI-LUMEN CATHETER (TLC). A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS INTENDED TO BE IMPLANTED IN THE LEFT RENAL ARTERY, HOWEVER, IT WAS LEFT IMPLANTED IN THE RIGHT INNOMINATE ARTERY. IT WAS REPORTED THE PHYSICIAN REACHED THE LEFT RENAL ARTERY AND PULLED THE DEPLOYMENT LINE ALL THE WAY. HOWEVER, THE PHYSICIAN HAD DIFFICULTY VISUALIZING IF THE VIABAHN ENDOPROSTHESIS EXPANDED PROPERLY UNDER FLUOROSCOPIC IMAGING. THE DELIVERY CATHETER WAS THEN WITHDRAWN AND IT WASN¿T UNTIL THE PHYSICIAN WAS AT THE RIGHT INNOMINATE ARTERY WHEN THEY NOTICED THE VIABAHN ENDOPROSTHESIS DID NOT DEPLOY IN THE LEFT RENAL ARTERY. WHEN BEING WITHDRAWN, THE VIABAHN DEVICE MET RESISTANCE BY GETTING CAUGHT ON AN UNSPECIFIED MATERIAL, CAUSING THE VIABAHN ENDOPROSTHESIS TO DISLODGE INTO THE RIGHT INNOMINATE ARTERY. THE VIABAHN ENDOPROSTHESIS DID NOT COVER ANY MAJOR BRANCH VESSELS, AND THE RIGHT INNOMINATE ARTERY STILL HAD PROPER BLOOD FLOW. THE VIABAHN ENDO

  Patient problems: Foreign Body In Patient

  MAUDE report 25193268 ↗
• MalfunctionSep 12, 2025Material Puncture/Hole; Device Damaged by Another Device; Material Puncture/Hole; Device Damaged by Another Device

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR A LESION IN THE COMMON FEMORAL ARTERY (CFA) WHERE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS ATTEMPTED TO BE USED. IT WAS REPORTED DURING THE PROCEDURE, WHILE ADVANCING THE VIABAHN DEVICE OVER A 0.035" GLIDEWIRE GUIDEWIRE THROUGH A COOK 8FR INTRODUCER SHEATH, THE PHYSICIAN NOTED RESISTANCE AND SUSPECTED THAT THE GUIDEWIRE WAS NOT PASSING THROUGH THE LUMEN OF THE COMMON FEMORAL ARTERY (CFA). FLUOROSCOPIC IMAGING CONFIRMED THAT THE GUIDEWIRE WAS NOT WITHIN THE LUMEN OF THE COMMON FEMORAL ARTERY (CFA). TO ADDRESS THIS, THE PHYSICIAN WITHDREW THE GUIDEWIRE AND PLANNED TO USE THE VIABAHN DEVICE CATHETER TO EXCHANGE FOR A SMALLER GUIDEWIRE (0.014"). THE PHYSICIAN WANTED TO USE A SMALLER GUIDEWIRE TO GET BACK TRUE LUMEN; HOWEVER, UPON ATTEMPTING TO INSERT THE 0.014" GUIDEWIRE INTO THE VIABAHN DEVICE CATHETER, IT APPEARED THAT THE GUIDEWIRE MAY HAVE PUNCTURED THE DISTAL END OF THE CATHETER JUST PROXIMAL TO THE AREA WHERE THE DEPLOYMENT LINE AND VIABAHN DEVICE ARE LOCATED. AS A RESULT, THE 0.014" GUIDEWIRE DID NOT EXIT PROPERLY THROUGH THE WIRE LUMEN. REPORTEDLY, THE CATHETER IS STILL ONE PIECE ALTHOU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23034890 ↗
• MalfunctionJan 17, 2025Activation Failure; Activation Failure

  ON (B)(6) 2025, PATIENT UNDERWENT TREATMENT FOR A RIGHT COMMON CAROTID ARTERY UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE). IT WAS REPORTED THAT DURING A PROCEDURE, THE VIABAHN® DEVICE WOULD NOT DEPLOY. RESISTANCE WAS MET IMMEDIATELY AND THE VIABAHN® DEVICE WAS FLEXING. A GUIDEWIRE GLIDEWIRE ADVANTAGE® .035 AND A COOK BRAND 8FR SHEATH WAS USED. THE PROCEDURE WAS COMPLETED USING ANOTHER VIABAHN® DEVICE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183798 ↗
• MalfunctionNov 13, 2024Separation Failure; Separation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2024, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE CEPHALIC ARCH VEIN DURING TREATMENT OF STENOSIS. IT WAS REPORTED THAT LEFT ARM BRACHIAL ACCESS WAS GAINED WITH AN 0.035" AMPLATZ SUPER STIFF GUIDE WIRE, THROUGH AN 8 FR X 11 CM TERUMO INTRODUCER SHEATH. THE PHYSICIAN PERFORMED AN ANGIOPLASTY WITH A 5MM BOSTEN SCIENTIFIC MUSTANG BALLOON AND AGAIN WITH AN 8 MM BOSTEN SCIENTIFIC MUSTANG BALLOON. AFTER THE VSX DEVICE WAS SUCCESSFULLY DELIVERED, THE PHYSICIAN FELT RESISTANCE WHEN ATTEMPTING TO REMOVE THE DELIVERY CATHETER. AFTER MULTIPLE ATTEMPTS, THE PHYSICIAN CONTINUED TO PULL AND THE DELIVERY CATHETER WAS REMOVED. AFTER THE REMOVAL OF THE DELIVERY CATHETER, THE PHYSICIAN OBSERVED THAT THE DISTAL TIP HAD BECOME DISLODGED INSIDE THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE DISLODGED DISTAL TIP WITH A COOK NSNARE¿ STENT RETRIEVER. HOWEVER, DURING THE ATTEMPTED REMOVAL, THE DISTAL TIP MIGRATED AND EMBOLIZED INTO A BRANCH VESSEL. THE DECISION WAS MADE TO LEAVE THE DISTAL TIP IN THE EMBOLIZED BRANCH VESSEL. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20674832 ↗
• MalfunctionJul 22, 2024Activation Failure; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR STENOTIC OCCLUSION WHERE A 9 MM X 5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (GORE® VIABAHN® DEVICE) WAS USED IN THE RIGHT ILIAC ARTERY. IT WAS REPORTED THE LESION WAS PREDILATED, AND THE PHYSICIAN ACCESSED THE PATIENT USING A 8F TERUMO GUIDING SHEATH OVER AN UNKNOWN GUIDEWIRE TO THE TARGET TREATMENT ZONE. REPORTEDLY, THE DEPLOYMENT LINE WAS PULLED, AND DEPLOYMENT INITIATED. THE ENDOPROSTHESIS EXPANDED HALFWAY WHEN THE DEPLOYMENT LINE CAME COMPLETELY OUT OF THE DELIVERY CATHETER, LEAVING THE PROXIMAL HALF OF THE STENT CONSTRAINED AND BUNCHED UP. THE PHYSICIAN WITHDREW THE CATHETER, BUT THE PARTIALLY EXPANDED ENDOPROSTHESIS REMAINED IN THE ARTERY. IT WAS REPORTED THE DEPLOYMENT LINE DID NOT GET CAUGHT ON ANYTHING (NO OTHER STENTS IN AREA). THE DECISION WAS MADE TO ADVANCE A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER INTO THE LUMEN OF THE STENT TO OPEN THE CONSTRAINED HALF AND TO FULLY EXPAND THE ENDOPROSTHESIS. UNDER FLUOROSCOPY GOOD WALL APPOSITION WAS OBSERVED. IT WAS REPORTED THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19794146 ↗
• MalfunctionFeb 26, 2024Break; Activation Failure; Break; Activation Failure

  ON (B)(6) 2024, A PATIENT UNDERWENT TREATMENT FOR A THROMBOSED ARTERIOVENOUS (AV) FISTULA USING A 9 MM X 5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) IN THE LEFT AXILLARY VEIN. IT WAS REPORTED THE DELIVERY CATHETER WAS ADVANCED USING AN UNKNOWN BRAND / SIZE INTRODUCER SHEATH OVER AN UNKNOWN BRAND / SIZE GUIDEWIRE TO THE TARGET TREATMENT SITE. REPORTEDLY, THE DEPLOYMENT LINE WAS PULLED AND BROKE. THE ENDOPROSTHESIS DID NOT DEPLOY. IT IS UNKNOWN HOW THE DELIVERY CATHETER WAS WITHDRAWN FROM THE PATIENT. IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18779536 ↗
• MalfunctionMar 8, 2022Break; Difficult or Delayed Activation; Break; Difficult or Delayed Activation

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2022, A PATIENT PRESENTED WITH AN UNKNOWN ETIOLOGY AND UNDERWENT TREATMENT OF A SUPERFICIAL FEMORAL ARTERY (SFA) UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VSX) DEVICE. THE PHYSICIAN ADVANCED THE VSX DEVICE TO THE INTENDED SITE USING A 0.014" TERUMO GLIDEWIRE ADVANTAGE® GUIDEWIRE. IT WAS REPORTED THAT THE PHYSICIAN INITIATED DEPLOYMENT AND WHEN THE DEVICE WAS APPROXIMATELY 2/3 OF THE WAY EXPANDED, THE DEPLOYMENT LINE BROKE. ULTIMATELY, THE PHYSICIAN WAS ABLE TO ACHIEVE FULL EXPANSION AND THE VSX DEVICE WAS SUCCESSFULLY IMPLANTED. ALL DELIVERY SYSTEM COMPONENTS WERE REMOVED FROM THE PATIENT. THE PATIENT TOLERATED THE PROCEDURE WITH NO ADVERSE IMPACTS. THE PHYSICIAN DOES NOT HAVE ANY INPUT AS TO WHAT CAUSED THE DEPLOYMENT LINE TO BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13693045 ↗
• MalfunctionSep 14, 2021Premature Activation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2021, THE PATIENT UNDERWENT TREATMENT OF A STENOTIC LESION IN THE LEFT AXILLARY VEIN USING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THE DEVICE MET RESISTANCE WHILE ADVANCING THROUGH THE AXILLARY VEIN. IT WAS ALSO NOTED THAT THE DEVICE UNINTENTIONALLY PARTIALLY DEPLOYED WHILE BEING ADVANCED. THE DEVICE WAS ABLE TO BE WITHDRAWN THROUGH THE SHEATH AND REMOVED FROM THE PATIENT. THE PHYSICIAN STATED SHE BELIEVES THE STENOSIS CAUSED THE PREMATURE DEPLOYMENT. ANOTHER GORE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12469128 ↗