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Fluency® Endovascular Stent Graft FEL08040Recalls & reported problems

Bard Peripheral Vascular, Inc. · FLUENCY® PLUS Endovascular Stent Graft 8 mm x 40 mm (117 cm delivery system) · Class 3 · Implant

All models of Fluency Endovascular Stent Graft (51)

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 04049519008134), received between Feb 2, 2017 and Feb 2, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Positioning Failure” (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

  • Positioning Failure1

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.

  • MalfunctionFeb 2, 2017Positioning Failure; Positioning Failure

    IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6296868 ↗

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Sources and updates

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