Skip to content

GORE VIABAHN Endoprosthesis VBCR060202ARecalls & reported problems

W. L. Gore & Associates, Inc. · VIABAHN SX ENDO 35 RO 6mmX2.5cm 7Fr 120cmCath · 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
1
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132623365), received between Jan 23, 2020 and Jan 23, 2020 — classified as 1 death.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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

  • Improper or Incorrect Procedure or Method1

Patient problems

  • Aneurysm1

Recent adverse event reports

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

  • DeathJan 23, 2020Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    THE FOLLOWING WAS REPORTED TO GORE: THE PATIENT PRESENTED FOR AORTIC ANEURYSM REPAIR. THE DOCTOR CUT THE VIABAHN AND SEWED A LITTLE SECTION ONTO THE EXTERIOR OF THE COOK ZENITH® FENESTRATED AAA ENDOVASCULAR GRAFT ON THE BACK TABLE. THE DOCTOR REPORTED TO GORE THAT THERE WAS DIFFICULTY IN ACCESSING THE RENAL ARTERY WITH THE FENESTRATION. THE PROCEDURE LASTED APPROXIMATELY 12 HOURS. THE DOCTOR REPORTED THE PATIENT DIED AS A RESULT OF HEART ISSUES.

    Patient problems: Aneurysm

    MAUDE report 9622705 ↗

Other System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment devices

All System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page