GORE VIABAHN Endoprosthesis VBCR101002ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132645824), received between Dec 15, 2022 and Sep 8, 2026 — classified as 4 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.

• MalfunctionSep 8, 2026Activation Failure; Physical Resistance/Sticking

  On (b)(6) 2026, a patient underwent an endovascular procedure to treat a stenotic occlusion at the venous outflow anastomosis of an arteriovenous access graft (brand unknown) using a 10 mm x 10 cm GORE® VIABAHN® Endoprosthesis.It was reported that the delivery catheter advanced through an 8 Fr TERUMO Introducer Sheath over a 0.035-inch TERUMO GLIDWIRE Guidewire to the target treatment site.During deployment of the endoprosthesis, the deployment line was pulled and met resistance at the distal turnaround point of the endoprosthesis. The decision was made to stop deployment. The delivery system was removed from the patient successfully with the catheter intact. It was reported that there was no distal expansion of the endoprosthesis. An attempt was made to deploy the endoprosthesis on the back table, However, this was unsuccessful. To complete the procedure, another GORE® VIABAHN® Endoprosthesis was used with an Amplatz Super Stiff Guidewire.It was reported that there was no impact to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50669438 ↗
• MalfunctionDec 5, 2025Activation Failure; Activation Failure

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A BASILIC VEIN OUTFLOW STENOSIS IN A DIALYSIS PATIENT, AN 8FR PINNACLE SHEATH WAS USED TO ADVANCE A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN® DEVICE) OVER AN .035 STIFF GLIDE WIRE. AS REPORTED, THERE WERE NO PRE-EXISTING DEVICES IN THE TREATMENT AREA. IT WAS REPORTED THE VIABAHN® DEVICE REACHED THE INTENDED TREATMENT AREA AND DEPLOYMENT WAS STARTED, BUT THE DEPLOYMENT LINE WOULD NOT RELEASE. THE PHYSICIAN TRIED SEVERAL MANEUVERS WITHOUT SUCCESS. THE CONSTRAINED VIABAHN® DEVICE WAS REMOVED. A NEW VIABAHN® DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ISSUES. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23733687 ↗
• MalfunctionJul 24, 2025Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  ON (B)(6) 2025, THE PATIENT UNDERWENT AN ENDOVASCULAR INTERVENTION TO ADDRESS GENERALIZED ARTERIAL DISEASE INVOLVING THE LEFT EXTERNAL ILIAC ARTERY. A GORE® VIABAHN® ENDOPROSTHESIS (VIABAHN DEVICE) WAS SUCCESSFULLY DEPLOYED AT THE INTENDED TREATMENT SITE. THE DEVICE WAS ADVANCED AND IMPLANTED WITHOUT RESISTANCE USING AN 8FR COOK MEDICAL INTRODUCER SHEATH AND A TERUMO 0.035" GLIDEWIRE ADVANTAGE® GUIDEWIRE. DURING THE ATTEMPTED WITHDRAWAL OF THE VIABAHN DELIVERY SYSTEM THROUGH THE SHEATH, RESISTANCE WAS ENCOUNTERED. THE PHYSICIAN APPLIED ADDITIONAL FORCE, AND UPON REMOVAL, IT WAS OBSERVED THAT THE DISTAL TIP OF THE DELIVERY SYSTEM HAD DETACHED AND REMAINED WITHIN THE PATIENT. THE DETACHED COMPONENT WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE. THE PATIENT¿S VASCULAR ANATOMY DEMONSTRATED TYPICAL CALCIFICATION AND TORTUOSITY. THERE WERE NO REPORTED ADVERSE EFFECTS OR CLINICAL IMPACT TO THE PATIENT AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589500 ↗
• MalfunctionDec 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE SUBCLAVIAN ARTERY FOR TREATMENT OF IN-STENT STENOSIS. AFTER THE VSX DEVICE WAS ADVANCED THROUGH THE PREVIOUSLY IMPLANTED DEVICE, THE PHYSICIAN-INITIATED DEPLOYMENT. AFTER APPROXIMATELY HALF OF THE DEVICE HAD BEEN DEPLOYED, THE DEPLOYMENT LINE BROKE. THE PHYSICIAN CUT THE DEPLOYMENT CATHETER TO TRY AND RETRIEVE THE DEPLOYMENT LINE, WITH NO SUCCESS. THE PHYSICIAN STARTED TO MANIPULATE THE DELIVERY CATHETER AND INTRODUCER SHEATH AND THE REMAINING VSX DEVICE DEPLOYED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15992510 ↗