Fluency® Endovascular Stent Graft FEL08060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04049519008141), received between Mar 1, 2016 and Sep 29, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING FLUENCY DEVICE. DURING PROCEDURE, THE WIRE PORT DETACHED FROM THE HUB WHEN DISCONNECTING THE FLUSH SYRINGE. THE ISSUE WAS IDENTIFIED BEFORE DEPLOYMENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23164590 ↗
• MalfunctionApr 8, 2020Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL (B)(4) ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, MATERIAL PERFORATION, AND MIFIRE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENTS AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941356 ↗
• MalfunctionMar 1, 2016Fracture; Activation, Positioning or Separation Problem; Break; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE CATHETER OF THE DELIVERY SYSTEM BROKE DURING DEPLOYMENT. THE STENT GRAFT WAS DEPLOYED WITH ADDITIONAL MANIPULATION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5469625 ↗