GORE VIABAHN Endoprosthesis with Heparin VBHR130502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132646128), received between Apr 27, 2023 and Mar 6, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Activation Failure” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 6, 2026Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: DURING A PROCEDURE FOR A CENTRAL VENOUS STENOSIS, ACCESS WAS MADE FROM THE BRACHIO-CEPHALIC ARTERY AND THE SUPERFICIAL FEMORAL ARTERY. AMPLATZ WIRES WERE INSERTED AND 10FR SHEATHS (UNSPECIFIED BRAND) WERE PLACED. A 13 X 10 GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN® DEVICE) WAS ADVANCED FROM THE BRACHIAL ACCESS AND IMPLANTED SUCCESSFULLY. NEXT, A 13 X 5 VIABAHN® DEVICE WAS ADVANCED FROM THE FEMORAL ACCESS TO THE TREATMENT SITE. DEPLOYMENT WAS STARTED, BUT THE DEPLOYMENT LINE DID NOT RELEASE. THE CONSTRAINED DEVICE WAS PULLED BACK INTO THE SHEATH FOR REMOVAL. HOWEVER, THE VIABAHN® DEVICE WAS STUCK AND DID NOT EXIT THE SHEATH. THE SHEATH AND VIABAHN® DEVICE WERE REMOVED TOGETHER. AS REPORTED, A SMALL PIECE OF WHAT APPEARED TO BE THE PATIENT'S ARTERY WAS FOUND ON THE REMOVED DEVICES. A NEW SHEATH WAS PLACED AND A NEW 13 X 5 VIABAHN® DEVICE WAS IMPLANTED WITH NO FURTHER ISSUES. IT WAS REPORTED THE PATIENT TOLERATED THE PROCEDURE AND IS RECOVERING WELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24533270 ↗
• MalfunctionOct 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT TREATMENT FOR AN ANEURYSMAL POPLITEAL ARTERY. IT WAS REPORTED A V-18 BOSTON 0.018" GUIDEWIRE WAS USED TO ADVANCE A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE VIABAHN DEVICE OVER A GORE® DRYSEAL FLEX INTRODUCER SHEATH. A 10MM X 15CM VIABAHN DEVICE WAS IMPLANTED IN THE DISTAL POPLITEAL ARTERY WITHOUT COMPLICATION AND SUCCESSFUL IMPLANTATION WAS ACHIEVED. NEXT, A 13MM X 5CM VIABAHN DEVICE WAS ADVANCED AND DEPLOYED. HOWEVER, DURING POST-DILATION, IT WAS REALIZED THE DISTAL TIP OF THE 13MM X 5CM VIABAHN DELIVERY SYSTEM HAD MIGRATED INTO THE PERONEAL ARTERY. USING A SNARE, THE DISTAL TIP WAS RETRIEVED. THE PHYSICIAN CONFIRMED THAT NO FOREIGN MATERIAL REMAINED IN THE PATIENT. AFTER POST DILATION USING A MEDTRONIC EVERCROSS BALLOON, THE PROCEDURE WAS COMPLETED WITH GOOD RESULTS. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES. AS REPORTED, THE CATHETER APPEARED TO HAVE A CLEAN BREAK, SUGGESTING THE CATHETER MAY HAVE BEEN SEVERED PRIOR TO INSERTION. NO EXCESSIVE FORCE WAS APPLIED DURING THE PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23336588 ↗
• MalfunctionJun 27, 2024Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A COMMON ILIAC ARTERY ANEURYSM, A 10FR TERUMO SHEATH WAS USED TO ADVANCE THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) OVER AN ADVANTAGE WIRE. THE VIABAHN DEVICE REACHED THE TARGET TREATMENT AREA. AT THIS TIME, THE PHYSICIAN WAS UNABLE TO UNTWIST THE DEPLOYMENT KNOB AS IT APPEARED TO BE STUCK. THE CONSTRAINED VIABAHN DEVICE WAS REMOVED WITH NO ISSUES AND ANOTHER VIABAHN DEVICE WAS ADVANCED AND DEPLOYED WITH NO ISSUES. ON THE BACK TABLE, THE DEPLOYMENT KNOB WAS ABLE TO BE UNSCREWED WITHOUT TOO MUCH FORCE. DEVICE WAS DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19629932 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, THIS PATIENT UNDERWENT EMERGENT ENDOVASCULAR TREATMENT OF A ZONE 2 TYPE B DISSECTION WITH MALPERFUSION, AND WAS IMPLANTED WITH A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS (TBE) WITH COVERAGE OF THE LEFT SUBCLAVIAN ARTERY (LSA). THREE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICES) WERE IMPLANTED AS BRANCH DEVICES WITHIN THE LSA AS THE APPROPRIATELY SIZED SIDE BRANCH DEVICES WERE NOT AVAILABLE. ADDITIONALLY, IT WAS REPORTED THAT DURING ADVANCEMENT OF THE TBE DEVICE, THE PHYSICIAN ENCOUNTERED ALOT OF DIFFICULTY POSITIONING THE TBE DEVICE TO ALIGN PROPERLY TO THE GREATER CURVE. THE TBE DEVICE HAD BEEN WITHDRAWN BACK DOWN TO THE DESCENDING THORACIC AORTA AT LEAST TEN TIMES IN AN ATTEMPT TO GET THE PORTAL TO LINE UP; AS IT KEPT FLIPPING TO THE LESSER CURVE OF THE AORTA AS OPPOSED TO THE GREATER CURVE. THE DEVICE WAS ALSO COMPLETELY REMOVED FROM THE SHEATH AND REINSERTED IT BACK INTO THE SHEATH IN HOPES OF GETTING IT TO TRACK AND ALIGN BETTER. ADDITIONALLY, IT WAS REPORTED THAT DURING ALL THE EXCESSIVE DEVICE MANIPULATION, THAT THE LUNDERQUIST WIRE PARKED IN THE ASCENDING THORACIC AORTA HAD BEEN DRAGGED BACK TO THE LEVEL OF THE DESCENDING AO

  Patient problems: Stroke/CVA

  MAUDE report 16827127 ↗