GORE VIABAHN Endoprosthesis with Heparin VBHR090702ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132645961), received between Aug 26, 2025 and Aug 26, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Lack of Effect” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2025Lack of Effect; Lack of Effect

  THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2025, A PATIENT WAS TREATED FOR A THORACIC ANEURYSM USING A GORE® TAG® THORACIC BRANCH ENDOPROSTHESIS SYSTEM. A GORE® VIABAHN® ENDOPROSTHESIS (VSX DEVICE) WAS IMPLANTED AS AN EXTENSION INTO THE SUBCLAVIAN ARTERY. ON AN UNKNOWN DATE, THE PATIENT REPORTED PAIN IN HER LOWER LEFT LEG. WHILE EVALUATING THE PAIN, AN MRI SHOWED EVIDENCE OF MULTIPLE SMALL STROKES. REPORTEDLY, THE PATIENT IS RECOVERING. BECAUSE THE SYMPTOMS OF THE STROKES ARE MINIMAL, NO TREATMENT IS BEING GIVEN AT THIS TIME. 2203-A USED TO CAPTURE MULTIPLE SMALL STROKES WITH THE VSX DEVICE.

  Patient problems: Ischemia Stroke; Pain

  MAUDE report 22899493 ↗