Fluency® Endovascular Stent Graft FEM06060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049519008394), received between Dec 7, 2017 and Sep 12, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 12, 2024Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20199339 ↗
• MalfunctionMay 6, 2024Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY UNABLE TO CROSS LESION IN CEPHALIC VEIN. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19246979 ↗
• MalfunctionApr 5, 2018Positioning Failure; Fracture; Difficult to Remove; Positioning Failure; Fracture; Difficult to Remove

  IT WAS REPORTED THAT DURING AN A/V GRAFT PLACEMENT PROCEDURE VIA THE LEFT UPPER ARM THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY AND WAS ALLEGEDLY DIFFICULT TO REMOVE, HOWEVER, IT WAS NOT STUCK WITHIN THE SHEATH. REPORTEDLY, ANOTHER ENDOVASCULAR STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7399996 ↗
• MalfunctionDec 7, 2017Positioning Failure; Difficult to Remove; Misfire; Positioning Failure; Difficult to Remove; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN THE LEFT ARM, THE STENT HAD ALLEGEDLY FAILED TO DEPLOY. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7098485 ↗