GORE VIABAHN Endoprosthesis with Heparin VBHR062502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132622863), received between Dec 14, 2023 and Jun 26, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryJun 26, 2025Material Fragmentation; Material Fragmentation

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS INTENDED FOR USE IN THE SUPERFICIAL FEMORAL ARTERY DURING TREATMENT OF STENOSIS. DURING THE ADVANCEMENT OF A 6MM X 25CM VSX DEVICE INTO A 6FR X 55CM COOK RAABE INTRODUCER SHEATH OVER AN 0.018" V18 GUIDE WIRE, THE DEVICE HAD GOT STUCK IN THE VALVE OF THE INTRODUCER SHEATH. THE VSX DEVICE AND INTRODUCER SHEATH WERE REMOVED. A 7FR X 55CM COOK RAABE INTRODUCER SHEATH WAS ADVANCED AND A NEW 6MM X 25CM VSX DEVICE WAS SUCCESSFULLY IMPLANTED ACROSS THE LESION. HOWEVER, AFTER THE DELIVERY CATHETER WAS REMOVED FROM THE PATIENT, THE DISTAL TIP WAS OBSERVED TO BE MISSING. THE PHYSICIAN PERFORMED AN ANGIOGRAM AND SAW THAT THE DISTAL TIP HAD MIGRATED DOWN TO THE POPLITEAL ARTERY. THE PHYSICIAN ATTEMPTED TO SNARE THE DISTAL TIP WITH NO SUCCESS. THE PATIENT WAS MOVED TO THE OPERATING ROOM, AND THE PHYSICIAN PERFORMED A CUT DOWN AND REMOVED THE DISTAL TIP. IT WAS NOTED THAT THE PHYSICIAN FELT RESISTANCE ADVANCING THE VSX DEVICE THROUGH THE STENOSIS.

  Patient problems: Foreign Body Embolism

  MAUDE report 22340794 ↗
• MalfunctionDec 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING WAS REPORTED TO GORE: DURING TREATMENT OF A STENOTIC OCCLUSION IN THE PATIENT'S LEFT SUPERFICIAL FEMORAL ARTERY, ACCESS WAS MADE FROM THE CONTRALATERAL SIDE. A 7FR X 45CM TERUMO SHEATH WAS USED TO ADVANCE THE FIRST GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) OVER A .035 GUIDEWIRE (BRAND NOT SPECIFIED). AS REPORTED, THE PHYSICIAN DID NOT PRE-DILATE THE STENOTIC OCCLUSION AND WAS PUSHING THE DEVICE WITH SOME FORCE. HOWEVER, THE DEVICE DID NOT CROSS THE LESION. THE VIABAHN DEVICE WAS PULLED BACK THROUGH THE SHEATH. AFTER DILATING THE TARGET LESION, THE SAME VIABAHN DEVICE WAS ADVANCED AGAIN AND WAS DEPLOYED. WHEN PULLING THE CATHETER BACK THROUGH THE SHEATH, THE DISTAL TIP GOT CAUGHT AT THE EDGE OF THE SHEATH AND THE CATHETER BROKE. AS REPORTED, THE BROKEN PIECE WAS PULLED OUT THROUGH THE SHEATH AS IT WAS NEAR THE OPENING OF THE SHEATH. IT WAS REPORTED THE DELIVERY CATHETER SEPARATION WAS AT THE SHEATH OPENING AND IT WAS CLOSE ENOUGH TO PULL OUT MANUALLY. A SECOND VIABAHN DEVICE WAS IMPLANTED, OVERLAPPING THE FIRST DEVICE IN THE SAME ANATOMICAL LOCATION. THE PATIENT IS REPORTED TO BE DOING WELL FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18333046 ↗