GORE VIABAHN Endoprosthesis with Heparin VBHR070502ARecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00733132622948), received between Nov 13, 2024 and Mar 24, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionMar 24, 2025Break; Break

  ON (B)(6) 2025, A PATIENT WITH BILATERAL LOWER-LIMB BYPASS GRAFTS, UNDERWENT LEFT LEG BYPASS REVISION (BRAND OF GRAFTS AND DATE OF INITIAL IMPLANT UNKNOWN). IT WAS REPORTED THE PATIENT DID NOT TAKE ANTICOAGULANT MEDICATION FOR AT LEAST 12 DAYS. ON (B)(6) 2025, THE PATIENT PRESENTED WITH LOWER LIMB THREATENING ISCHEMIA OF UNKNOWN DURATION. IT WAS NOTED THERE WAS THROMBOSIS IN THE LEFT FEMORAL-TIBIAL BYPASS ARTERY BYPASS GRAFT, AND SEVERE STENOSIS IN THE LEFT EXTERNAL ILIAC ARTERY. THE DECISION WAS MADE TO USE A 7 MM X 5 CM GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE (VIABAHN DEVICE) IN THE SEVERELY STENOSED LEFT EXTERNAL ILIAC ARTERY. IT WAS REPORTED, THE LESION IN THE EXTERNAL ILIAC ARTERY WAS PRE-DILATED WITH A 6 MM X 60 MM ARMADA BALLOON. THE PHYSICIAN ACCESSED THE PATIENT USING A 10 F UNKNOWN BRAND INTRODUCER SHEATH OVER AN .035" TERUMO ADVANTAGE GUIDE WIRE (180 CM) TO THE TARGET TREATMENT SITE. REPORTEDLY, THE ENDOPROSTHESIS DEPLOYED. AFTER WITHDRAWAL OF THE DELIVERY SYSTEM CATHETER, IT WAS NOTICED THE DISTAL SECTION OF THE CATHETER WAS RETAINED INSIDE THE PATIENT. THE CASE WAS EXTENDED BY APPROXIMATELY 30 - 40 MINUTES AND ADDITIONAL HEPARIN WAS UTILIZED. THE B

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678264 ↗
• MalfunctionNov 13, 2024

  SCRUB TECH FLUSHED STENT AND SAW THAT IT WAS LEAKING AROUND SEAL THAT IS USED TO DEPLOY STENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20673652 ↗