GORE VIABAHN Endoprosthesis with Heparin VBHR061501ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132622825), received between Dec 4, 2025 and Dec 4, 2025 — classified as 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2025, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF STENOSIS IN A BARE METAL STENT (MANUFACTURER UNKNOWN) IN THE ILIAC ARTERY. REPORTEDLY, THE PHYSICIAN FELT RESISTANCE WHILE REMOVING THE DELIVERY CATHETER AFTER THE VSX DEVICE WAS SUCCESSFULLY DELIVERED. ONCE THE CATHETER WAS REMOVED, IT WAS OBSERVED TO BE MISSING THE DISTAL TIP. THE PHYSICIAN MADE THE DECISION TO LEAVE THE DISTAL TIP IN THE PATIENT. PATIENT SYMPTOM CODE, 2203, OTHER USED TO CAPTURE DISTAL TIP LEFT IN PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 23716202 ↗