Fluency® Endovascular Stent Graft FEL14100Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519008363), received between Dec 1, 2016 and Mar 1, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (2 reports).

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

Recent adverse event reports

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

• MalfunctionMar 1, 2019Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN THE RIGHT COMMON AND EXTERNAL ILIAC ARTERIES VIA ACCESS THROUGH THE RIGHT COMMON FEMORAL ARTERY WITH 90 DEGREE ANGULATION BETWEEN THE COMMON AND EXTERNAL ILIAC ARTERIES, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. THEREFORE, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8383118 ↗
• MalfunctionDec 1, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED ANY FURTHER AFTER BEING RELEASED A QUARTER OF THE WAY. REPORTEDLY, THERE WERE NO RETRACTION ISSUES AND THE PROCEDURE WAS COMPLETED BY USING A PTA BALLOON TO TAMPONADE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6137619 ↗