GORE VIABAHN Endoprosthesis with Heparin VBH101502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132623235), received between Nov 26, 2019 and May 11, 2020 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2020Patient-Device Incompatibility; Patient-Device Incompatibility

  ON (B)(6) 2020, THE PATIENT WAS BEING IMPLANTED WITH A GORE® VIABAHN® ENDOPROSTHESIS FOR AV ACCESS IN THE UPPER ARM. IT WAS REPORTED THE DEVICE MET RESISTANCE AND WAS UNABLE TO ADVANCE OVER THE LESION. THE PHYSICIAN STATED THE SUSPECTED CAUSE OF THE EVENT IS UNKNOWN. THE DEVICE WAS ATTEMPTED TO BE WITHDRAWN BACK INTO THE 11FR TRUMO SHEATH. HOWEVER, THE DEVICE COULD NOT BE PULLED BACK INTO THE SHEATH. THE DEVICE WAS THEN ADVANCED BACK TO THE PATIENTS UPPER ARM DEPLOYED AND SURGICALLY REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE PATIENT TOLERATED THE PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10043988 ↗
• InjuryNov 26, 2019Positioning Problem; Positioning Problem

  THE FSA PROVIDED THE FOLLOWING INFORMATION: ON OCTOBER 30, 2019, IT WAS REPORTED A GORE® VIABAHN® ENDOPROSTHESES WAS IMPLANTED. IT WAS REPORTED A 12 FR GORE® DRYSEAL FLEX INTRODUCER SHEATH WAS USED DURING THE PROCEDURE. REPORTEDLY, THE DEVICE BECAME STUCK WHILE PASSING THROUGH A PREVIOUSLY IMPLANTED DACRON GRAFT USED TO REPAIR A FEMORAL ARTERY ANEURYSM. IT WAS REPORTED THE PHYSICIAN ATTEMPTED TO WITHDRAW THE DEVICE INTO THE SHEATH, HOWEVER, THE DEVICE COULD NOT BE REMOVED. THE DEVICE WAS DEPLOYED WITHIN THE ANEURYSM PROXIMAL TO THE INTENDED SEAL ZONE. THE PATIENT WAS IMPLANTED WITH TWO GORE® VIABAHN® ENDOPROSTHESES IN THEIR INTENDED LOCATION WITHIN THE FEMORAL ARTERY. IT WAS REPORTED THE DEVICES SUCCESSFULLY EXCLUDED THE ANEURYSM. IT WAS REPORTED THE PHYSICIAN THEN PERFORMED A SURGICAL CONVERSION TO EXPLANT THE INITIAL DEVICE FROM THE FEMORAL ARTERY.

  Patient problems: No Code Available

  MAUDE report 9379678 ↗