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Fluency® Endovascular Stent Graft FEL07080Recalls & reported problems

Bard Peripheral Vascular, Inc. · FLUENCY® PLUS Endovascular Stent Graft 7 mm x 80 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
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519008103), received between Sep 27, 2016 and May 24, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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

  • Fracture1
  • Misfire1
  • Positioning Failure1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 24, 2023Fracture; Misfire; Fracture; Misfire

    IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE IN LEFT ARM GRAFT, THE STENT WAS ALLEGEDLY NOT FULLY DEPLOYED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16990433 ↗
  • MalfunctionSep 27, 2016Positioning 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 5980135 ↗

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Sources and updates

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