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Fluency® Endovascular Stent Graft FEL06100Recalls & reported problems

Bard Peripheral Vascular, Inc. · FLUENCY® PLUS Endovascular Stent Graft 6 mm x 100 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 04049519008066), received between Dec 12, 2016 and Dec 12, 2016 — 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.

  • MalfunctionDec 12, 2016Positioning Failure; Positioning Failure

    IT WAS REPORTED THAT DURING A TREATMENT OF AN ANEURYSM IN THE SFA THE ENDOVASCULAR STENT GRAFT FAILED TO DEPLOY. THE ACCESS SITE WAS GAINED CONTRALATERAL. THE ENDOVASCULAR STENT GRAFT SYSTEM WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6166121 ↗

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Sources and updates

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