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Fluency® Endovascular Stent Graft FEL14060Recalls & reported problems

Bard Peripheral Vascular, Inc. · FLUENCY® PLUS Endovascular Stent Graft 13.5 mm x 60 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04049519008349), received between Jul 4, 2016 and Jul 4, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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

  • Detachment Of Device Component1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjuryJul 4, 2016Detachment Of Device Component

    IT WAS REPORTED THAT DURING A SHEATHLESS STENT PLACEMENT PROCEDURE FOR TREATMENT OF A STENOSIS IN THE LEFT SUBCLAVIAN VEIN VIA ACCESS THROUGH THE CEPHALIC VEIN, THE RADIOPAQUE MARKER OF THE STENT DELIVERY SYSTEM BECAME DETACHED. REPORTEDLY, THE RADIOPAQUE MARKER PINCHED THE STENT GRAFT CLOSED ON THE DISTAL END. A SNARE DEVICE WAS UNSUCCESSFULLY USED TO CAPTURE AND RETRIEVE THE MARKER. A SECOND STENT GRAFT WAS DEPLOYED TO FIX THE RADIOPAQUE MARKER AGAINST THE VESSEL WALL. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 5767932 ↗

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Sources and updates

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