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GORE VIABAHN Endoprosthesis VBCR070501ARecalls & reported problems

W. L. Gore & Associates, Inc. · VIABAHN SX ENDO 35 RO 7mmX5cm 8Fr 75cmCath · Class 3 · Implant

All models of GORE VIABAHN Endoprosthesis (26)

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 00733132623433), received between Aug 21, 2018 and Aug 21, 2018 — classified as 1 malfunction.

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

Device problems

  • Break1

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.

  • MalfunctionAug 21, 2018Break; Break

    THE FOLLOWING WAS REPORTED TO GORE BY THE CUSTOMER: THE DIALYSIS PATIENT WAS BEING TREATED FOR A VEIN STENOSIS. THE GORE® VIABAHN® ENDOPROSTHESIS WAS ADVANCED ON A BENSON .035 WIRE TO THE TARGET LOCATION AND DEPLOYED WITHOUT INCIDENT. DURING REMOVAL, THE DOCTOR REPORTED A SLIGHT RESISTANCE. WHEN THE CATHETER WAS REMOVED, THE DOCTOR OBSERVED THAT THE TIP AND PART OF THE SHAFT HAD BROKEN OFF AND WERE STILL ON THE WIRE. THE TIP AND SHAFT WERE REMOVED SEPARATELY. THE DOCTOR REPORTED THE PATIENT IS FINE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7803370 ↗

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Sources and updates

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