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GORE VIABAHN Endoprosthesis with Heparin VBJR080702ARecalls & reported problems

W. L. Gore & Associates, Inc. · VIABAHN SX ENDO HEPARIN 18 RO 8mmX7.5cm 7Fr 120cm Cath · 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00733132624119), received between Aug 9, 2023 and Aug 9, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Obstruction of Flow” (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

  • Obstruction of Flow1

Patient problems

  • Obstruction/Occlusion1

Recent adverse event reports

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

  • InjuryAug 9, 2023Obstruction of Flow; Obstruction of Flow

    THE FOLLOWING WAS REPORTED TO GORE: ON (B)(6) 2023, A PATIENT RECEIVED TREATMENT FOR A SUBCLAVIAN ARTERY STENOSIS. A GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WAS IMPLANTED. DURING THE PATIENT'S FOLLOW-UP ON (B)(6) 2023, THE DEVICE WAS FOUND TO BE OCCLUDED. THE PHYSICIAN CHOSE A WAIT AND SEE APPROACH. NO INTERVENTION WAS PERFORMED OR SCHEDULED. AS REPORTED, THE PATIENT WAS ASYMPTOMATIC.

    Patient problems: Obstruction/Occlusion

    MAUDE report 17491791 ↗

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Sources and updates

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