Fluency® Endovascular Stent Graft FEM09120Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04049519008578), received between Nov 18, 2015 and Apr 12, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 12, 2023Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR VENOUS ANASTOMOSIS, THE STENT ALLEGEDLY FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16726027 ↗
• MalfunctionJul 14, 2020Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM09120 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10272347 ↗
• MalfunctionApr 10, 2020Retraction Problem; Device-Device Incompatibility; Retraction Problem; Device-Device Incompatibility

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM09120 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A RETRACTION PROBLEM AND DEVICE-DEVICE INCOMPATIBILITY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE AGE, WEIGHT, AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9947947 ↗
• MalfunctionOct 14, 2019Fracture; Misfire; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM09120 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A FRACTURE AND MISFIRE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES TO THE PATIENT. THE ONE PATIENT WAS REPORTEDLY A (B)(6) YEAR OLD FEMALE WITH NO WEIGHT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9189145 ↗
• MalfunctionNov 24, 2015Positioning Failure; Fracture

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED ANY FURTHER AFTER BEING PARTIALLY RELEASED. ANOTHER STENT GRAFT WAS PLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5245362 ↗
• MalfunctionNov 18, 2015Positioning Failure; Fracture

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. DURING RETRACTION OF THE DELIVERY SYSTEM, THE SHAFT FRACTURED. ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5234431 ↗