Fluency® Endovascular Stent Graft FEL06080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519008059), received between Apr 26, 2017 and Sep 7, 2017 — classified as 2 malfunctions.

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

• MalfunctionSep 7, 2017Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM DURING TREATMENT OF A HEAVY CALCIFIED LESION IN THE LEFT FEMORAL BYPASS GRAFT. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED, EXCHANGED FOR ANOTHER, AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6849422 ↗
• MalfunctionApr 26, 2017Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING A FISTULAGRAM PROCEDURE, THE SHEATH OF THE DELIVERY SYSTEM BROKE AT THE HUB WHILE BEING DEPLOYED THROUGH A 9 F INTRODUCER SHEATH. REPORTEDLY, THE STENT GRAFT COULD BE IMPLANTED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6522364 ↗