Fluency® Endovascular Stent Graft FEL14040Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519008332), received between Sep 28, 2017 and Jul 10, 2024 — classified as 2 malfunctions.

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

• MalfunctionJul 10, 2024Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE INNOMINATE-SUBCLAVIAN VEIN JUNCTION VIA LEFT UPPER EXTREMITY BRACHIOCEPHALIC FISTULA, THE STENT ALLEGEDLY DID NOT DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19709023 ↗
• MalfunctionSep 28, 2017Positioning Failure; Fracture; Misfire; Difficult to Advance; Positioning Failure; Fracture; Misfire; Difficult to Advance

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE CEPHALIC ARCH, THE STENT GRAFT DELIVERY SYSTEM ALLEGEDLY FRACTURED. REPORTEDLY, THE DELIVERY SYSTEM WAS DIFFICULT TO ADVANCE TO THE TARGET LESION, THEREFORE THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY. IT WAS FURTHER REPORTED THAT THE STENT GRAFT WAS OBSERVED TO BE PARTIALLY DEPLOYED BUT DID NOT EXPAND. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6900704 ↗