GORE VIABAHN Endoprosthesis with Heparin VBJR070202ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00733132623754), received between May 26, 2022 and Jul 22, 2026 — classified as 1 injury, 3 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.

• MalfunctionJul 22, 2026Activation Failure

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25906642 ↗
• MalfunctionNov 18, 2025Activation Failure; Activation Failure

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN UNKNOWN ETIOLOGY WITH A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE). REPORTEDLY, AFTER THE DEVICE WAS ADVANCED ACROSS THE LESION, THE PHYSICIAN ATTEMPTED TO DEPLOY THE DEVICE. HOWEVER, AFTER DEPLOYMENT WAS INITIATED, THE DEPLOYMENT LINE WAS STUCK AND THE VSX DEVICE WAS REMOVED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586953 ↗
• MalfunctionJul 13, 2023Malposition of Device; Difficult to Open or Close; Malposition of Device; Difficult to Open or Close

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2023, A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) WAS USED IN THE LEFT SPLENIC ARTERY TO TREAT A SPLENIC ARTERY ANEURYSM. ACCESS WAS GAINED THROUGH THE LEFT RADIAL ARTERY WITH A BOSTON SCIENTIFIC V-18 GUIDEWIRE THROUGH A COOK 8 FR INTRODUCER SHEATH. IT WAS REPORTED WHEN THE PHYSICIAN PULLED THE VIABAHN DEVICE DELIVERY SYSTEM DEPLOYMENT LINE THE VIABAHN DEVICE STARTED TO DEPLOY AND EXPAND, HOWEVER, DID NOT REACH FULL EXPANSION BEFORE ENTERING THE SPLENIC ARTERY ANEURYSMAL SAC. THE VIABAHN DEVICE WAS REMOVED FROM THE PATIENT WITHOUT DIFFICULTY. THE PROCEDURE WAS COMPLETED WITH COIL EMBOLIZATION OF THE LEFT SPLENIC ARTERY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17322257 ↗
• InjuryMay 26, 2022Break; Break

  IT WAS REPORTED TO GORE THAT DURING A PROCEDURE TO TREAT THE CELIAC ARTERY WHILE USING A 7 FR OSCAR STEERABLE SHEATH WITH A 0.18" V18 BOSTON SCIENTIFIC GUIDEWIRE THE GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS UNABLE TO CROSS THE LESION. REPORTEDLY THE PHYSICIAN DID NOT PRE-DILATE THE LESION. IT WAS REPORTED THAT WHEN THE PHYSICIAN WAS ATTEMPTING TO PULL THE DEVICE BACK THROUGH THE SHEATH, THE DEVICE TIP GOT HUNG UP ON THE OSCAR SHEATH AND STARTED TO PARTIALLY DEPLOY. REPORTEDLY THE PHYSICIAN ATTEMPTED TO PULL THE SHEATH AND DEVICE DELIVERY SYSTEM OUT OF THE RIGHT COMMON FEMORAL ARTERY AND THE DEVICE DEPLOYED IN THE RIGHT EXTERNAL ILIAC ARTERY. IT WAS REPORTED THAT THE BLUE OLIVE TIP OF THE DELIVERY SYSTEM CAME OFF AND LODGED IN THE INTERNAL ILIAC ARTERY. REPORTEDLY THE PHYSICIAN CLOSED AND STATED THAT HE MAY ATTEMPT TO BRING HER BACK FOR ANOTHER PROCEDURE AT A LATER DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14518520 ↗