GORE VIABAHN Endoprosthesis with Heparin VBJR070502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00733132623761), received between Jan 16, 2020 and Sep 28, 2026 — classified as 2 deaths, 1 injury, 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 28, 2026Break; Activation Failure

  On (b)(6) 2026, the patient underwent treatment for stenosis using a GORE® VIABAHN® Endoprosthesis with HEPARIN Bioactive Surface (VIABAHN Device) that was intended to be placed in the right external iliac artery. It was reported the VIABAHN Device was advanced through a 7Fr (55 cm) COOK Flexor Ansel Guiding Sheath over a .018" (300 cm) ABBOTT Hi-Torque Steelcore Guidewire. Reportedly, the target treatment site was not predilated but the VIABAHN Device successfully reached the target treatment site. Upon attempted deployment, it was reported that the deployment line broke after an unknown length of the deployment line was pulled. It is unknown if there was any resistance felt. It was reported the endoprosthesis remained on the delivery catheter, fully constrained, and was removed in tandem with the delivery catheter through the sheath. Upon withdrawal, it was reported there was no endoprosthesis expansion noticed. Reportedly, there were no signs of delivery catheter breakage or detachment and no deployment line left inside the patient. It was reported there was no calcification and/or tortuous anatomy present. To complete the procedure, two new VIABAHN Devices were selected for use

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50917057 ↗
• MalfunctionJul 27, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50037846 ↗
• MalfunctionMar 6, 2026Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A LEFT CAROTID ARTERY STENOSIS, A 7FR TOUR GUIDE SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) TO THE STENOTIC LESION AREA. AS REPORTED, NO PRE-DILATION WAS PERFORMED. THE VIABAHN® DEVICE REACHED THE TARGET SITE AND DEPLOYMENT WAS STARTED. HOWEVER, THE DEPLOYMENT LINE WAS STUCK AFTER ABOUT TWO INCHES OF LINE UNRAVELING. THE CONSTRAINED VIABAHN® DEVICE WAS PULLED BACK THROUGH THE SHEATH WITH NO ISSUES. A NEW VIABAHN® DEVICE WAS IMPLANTED WITH NO ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. IT WAS REPORTED THE PHYSICIAN TRIED TO DEPLOY THE REMOVED DEVICE ON THE BACK TABLE, BUT THE DEPLOYMENT LINE BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24536540 ↗
• MalfunctionDec 19, 2025Break; Activation Failure; Physical Resistance/Sticking; Break; Activation Failure; Physical Resistance/Sticking

  ON (B)(6) 2025, A PATIENT UNDERWENT AN ENDOVASCULAR PROCEDURE FOR AN UNKNOWN ETIOLOGY IN AN UNSPECIFIED ANATOMICAL LOCATION UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE). REPORTEDLY, 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. DURING DEPLOYMENT, IT WAS REPORTED THE ENDOPROSTHESIS WOULD NOT DEPLOY. IT WAS REPORTED THERE WAS NO PATIENT HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23856705 ↗
• MalfunctionDec 4, 2024

  WHILE PERFORMING AN ANGIOGRAM, THE PHYSICIAN ATTEMPTED TO PLACE A STENT IN THE SPLENIC ARTERY. HE WAS UNABLE TO GET ACCURATE PLACEMENT; THEREFORE, HE REMOVED THE CATHETER WITH THE STENT UNDEPLOYED. HE EXPERIENCED DIFFICULTY PULLING THE CATHETER OUT AND ONCE THE CATHETER WAS OUT, HE NOTICED THE CATHETER, WHERE IT ATTACHES TO THE STENT, WAS BROKEN. NOTHING WAS LEFT IN THE BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20842148 ↗
• MalfunctionMay 6, 2024Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: DURING AN EMERGENCY PROCEDURE FOR A PATIENT WHO HAD A STAB WOUND IN THE LEFT AXILLARY ARTERY, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) DID NOT DEPLOY. AS REPORTED, ACCESS WAS MADE FROM THE COMMON FEMORAL ARTERY. A 7FR COOK SHEATH WAS USED TO ADVANCE THE VIABAHN DEVICE OVER A 0.035 AMPLATZ WIRE. WHEN THE VIABAHN DEVICE WAS PLACED, THE DEPLOYMENT LINE WAS PULLED BUT THE LINE WAS STUCK. AFTER SEVERAL ATTEMPTS, THE CONSTRAINED VIABAHN DEVICE WAS REMOVED. A NEW VIABAHN DEVICE WAS ADVANCED AND DEPLOYED AT THE INTENDED TREATMENT SITE WITH NO ISSUES. THE PATIENT IS REPORTED TO BE RECOVERING WELL FOLLOWING THE PROCEDURE. THE INABILITY TO DEPLOY DEVICE DID NOT ADVERSELY IMPACT THE PATIENT AS PHYSICIAN WAS ABLE TO USE ANOTHER DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19256003 ↗
• DeathApr 24, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS PROVIDED TO GORE: ON (B)(6) 2023, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE SPLENIC ARTERY FOR TREATMENT OF A PREEXISTING RUPTURE. FROM A RIGHT COMMON FEMORAL ARTERY APPROACH, THE VSX DEVISE WAS ADVANCE ACROSS THE ANEURYSM. THE PHYSICIAN THEN ATTEMPTED TO DEPLOY THE VSX DEVICE. HOWEVER, THE VSX DEVICE STARTED TO BOWSTRING AND WOULD NOT CONTINUE DEPLOYING. THE PHYSICIAN MADE SEVERAL ATTEMPTS TO CONTINUE DEPLOYMENT WITH NO SUCCESS. WITH NO DEVICE EXPANSION, THE PHYSICIAN THEN ATTEMPTED TO REMOVE THE VSX DEVICE THROUGH THE INTRODUCER SHEATH (MANUFACTURER UNKNOWN) WITH NO SUCCESS. THE DECISION WAS MADE TO REMOVE THE DEPLOYMENT SYSTEM AND INTRODUCER SHEATH IN TANDEM. HOWEVER, THE PROXIMAL END OF THE VSX DEVICE GOT HUNG UP AT THE ACCESS SITE. THE PHYSICIAN ATTEMPTED TO MANIPULATE THE DEVICE FOR REMOVAL, WHEN THE DELIVERY CATHETER BROKE. THERE WAS STILL WIRE ACCESS TO THE ARTERY AND THE RETAINED FRAGMENT OF THE DELIVERY SYSTEM, AND THE RETAINED STENT GRAFT WERE ON THE WIRE IN THE COMMON FEMORAL ARTERY (STILL NOT DEPLOYED AND COMPLETELY COLLAPSED OTHER THAN THE MOST PROXIMAL PORTION OF THE STENT GRAFT). THE SHEATH AND THE SHAFT O

  Patient problems: Ruptured Aneurysm

  MAUDE report 16796645 ↗
• InjuryOct 13, 2021Malposition of Device; Malposition of Device

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2021, A PATIENT PRESENTED WITH STENOSIS IN THE LEFT EXTERNAL ILIAC ARTERY AND UNDERWENT TREATMENT UTILIZING A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE DEVICE. THE PATIENT WAS UNDERGOING A LEFT KIDNEY BYPASS WITH AN OPEN CUT DOWN OVER THE LEFT FEMORAL ARTERY. DURING THE KIDNEY BYPASS, THE PHYSICIAN ALSO INTENDED TO PLACE A VIABAHN DEVICE IN THE LEFT EXTERNAL ILIAC ARTERY TO TREAT A STENOTIC LESION. THE VIABAHN DEVICE WAS SUCCESSFULLY DEPLOYED ACROSS THE LESION WITHOUT ISSUE. THE PHYSICIAN THEN ATTEMPTED TO PASS THE SHEATH THROUGH THE VIABAHN DEVICE, AT WHICH POINT ITS REPORTED THAT THE SHEATH GRABBED THE EDGE OF THE IMPLANTED ENDOPROSTHESIS AND PUSHED IT FORWARD AND INTO THE KIDNEY BYPASS BY APPROXIMATELY 2CM. THE PHYSICIAN ATTEMPTED TO REPOSITION THE VIABAHN DEVICE BY INSERTING A BALLOON AND PULLING THE DEVICE BACK INTO PLACE, BUT WAS UNSUCCESSFUL. BECAUSE THERE WAS ALREADY A LEFT FEMORAL CUT DOWN AS PART OF THE KIDNEY BYPASS, THE PHYSICIAN DECIDED TO EXTEND THE CUT DOWN A BIT HIGHER AND MANUALLY RETRIEVE THE VIABAHN DEVICE. THIS METHOD WAS SUCCESSFUL AND THE MALPOSITIONED DEVICE WAS EXPLANTED FROM THE PATIENT WITHOU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623751 ↗
• DeathMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THIS PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF A SYMPTOMATIC ABDOMINAL AORTIC ANEURYSM WITH SHORT DISTANCE CLAUDICATION OF BOTH LOWER EXTREMITIES AND BILATERAL ILIAC ARTERY OCCLUSIONS; WITH COMPLETE OCCLUSION OF THE RIGHT EXTERNAL ILIAC ARTERY (RCIA) AND LEFT COMMON ILIAC ARTERY (LCIA). POST DISSECTION OF THE BILATERAL CIA¿S A GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS (VBX STENT GRAFT) WAS ADVANCED AND DEPLOYED WITHIN THE RCIA AND EXTENDED WITH A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE DOWN TO THE REIA AND INFLATED TO 12MMHG. A 16 FR SHEATH WAS THEN ADVANCED THROUGH THE RIGHT ILIAC VIABAHN® SYSTEM AND A GORE® EXCLUDER® TRUNK IPSILATERAL LEG COMPONENT FEATURING C3® DELIVERY SYSTEM WAS ADVANCED AND DEPLOYED JUST DISTAL TO THE RENAL ARTERIES. A SECOND TRUNK IPSILATERAL LEG COMPONENT OF THE SAME SIZE WAS THEN ADVANCED AND DEPLOYED TO OVERLAP THE FIRST ONE. ANGIOPLASTY OF THE ENTIRE SYSTEM WAS PERFORMED ALL THE WAY DOWN TO THE COMMON AND EXTERNAL ILIAC¿S. COMPLETION ANGIOGRAPHY DEMONSTRATED NO ENDOLEAK AND A WIDELY PATENT GRAFT SYSTEM AND A FEMORAL TO FEMORAL ARTERY BYPASS WAS PERFORMED. AN ANGIOGRAPH WAS PERFORMED AND SHOWED TWO AREAS O

  Patient problems: Cardiogenic Shock; Hypovolemic Shock

  MAUDE report 11453378 ↗
• MalfunctionJan 16, 2020Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR AN EMERGENT AAA CASE BECAUSE OF AORTIC RUPTURE. THE GORE® VIABAHN® ENDOPROSTHESIS WAS PLACED IN ONE OF THE RENALS TO BE USED AS A SNORKEL. AS THE DEPLOYMENT LINE WAS BEING PULLED THE DEPLOYMENT LINE COULD NOT BE PULLED. THE DEVICE WAS SNAGGED FROM THE GROIN AND REMOVED. DURING REMOVAL THE DEVICE BEGAN TO OPEN. THE DEVICE WAS FULLY REMOVED FROM THE PATIENT.

  Patient problems: Aneurysm

  MAUDE report 9595999 ↗