Fluency® Endovascular Stent Graft FEL09120Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04049519008226), received between Aug 24, 2018 and Aug 24, 2018 — 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.

• MalfunctionAug 24, 2018Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING TREATMENT FOR A FAILED A/V GRAFT PROCEDURE, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE OUTER CATHETER SHEATH ALLEGEDLY FRACTURED. 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 7813858 ↗
• MalfunctionAug 24, 2018Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING TREATMENT FOR A FAILED A/V GRAFT PROCEDURE, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM. IT WAS FURTHER REPORTED THAT THE OUTER CATHETER SHEATH ALLEGEDLY FRACTURED. 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 7813422 ↗