Fluency® Endovascular Stent Graft FEL12060Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049519008295), received between Mar 13, 2017 and Oct 29, 2021 — classified as 4 malfunctions.

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

• MalfunctionOct 29, 2021Break; Positioning Failure; Material Invagination; Material Perforation; Break; Positioning Failure; Material Invagination; Material Perforation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WAS UNABLE TO BE DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12720898 ↗
• MalfunctionOct 20, 2021Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT, THE STENT ALLEGEDLY DEPLOYED PARTIALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12665579 ↗
• MalfunctionApr 8, 2019Fracture; Retraction Problem; Fracture; Retraction Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN THE LEFT COMMON ILIAC VEIN VIA ACCESS THROUGH THE LEFT POPLITEAL VEIN, AFTER SUCCESSFULLY DEPLOYING THE STENT GRAFT, THE DELIVERY SYSTEM ALLEGEDLY FAILED TO RETRACT AND THE CATHETER AND SHEATH WERE REMOVED AS ONE UNIT. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM ALLEGEDLY FRACTURED OUTSIDE OF THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8492137 ↗
• MalfunctionMar 13, 2017Positioning Failure; Material Perforation; Positioning Failure; Material Perforation

  IT WAS REPORTED THAT DURING A SHEATHLESS STENTING PROCEDURE OF A LEG GRAFT, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6399419 ↗