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GORE VIABAHN Endoprosthesis with Heparin VBH110502ARecalls & reported problems

W. L. Gore & Associates, Inc. · VIABAHN SX ENDO HEPARIN 35 11mmX5cm 11Fr120cmCath · Class 3 · Implant

All models of GORE VIABAHN Endoprosthesis with Heparin (62)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132623259), received between Nov 20, 2020 and Nov 20, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Premature Separation” (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

Device problems

  • Premature Separation1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 20, 2020Premature Separation; Premature Separation

    THE FOLLOWING INFORMATION WAS REPORTED TO GORE: ON (B)(6) 2020, A PATIENT WAS UNDERGOING A PROCEDURE OF UNKNOWN TYPE WITH A GORE® VIABAHN® ENDOPROSTHESIS. AFTER INSERTING THE DEVICE, A SEPARATION BETWEEN THE STENT AND THE CATHETER WAS NOTICED. ADDITIONALLY, THE STENT WAS IN A POSITION WHERE IT WOULD NOT DEPLOY PROPERLY THE DEVICE AND DELIVERY SYSTEM WERE REMOVED, AND ANOTHER DEVICE WAS UTILIZED SUCCESSFULLY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10880284 ↗

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Sources and updates

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