Fluency® Endovascular Stent Graft FEM06080Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04049519008400), received between Oct 14, 2019 and Jan 21, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Misfire” (5 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.

• MalfunctionJan 21, 2025Break; Fracture; Misfire; Break; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THERE WAS MILD RESISTANCE TO DEPLOYMENT AT FIRST. AFTER SOME TIME APPROXIMATELY ONE FIFTH OF DEVICE DEPLOYED. IT WAS FURTHER REPORTED THAT THERE WAS SIGNIFICANT RESISTANCE AND THE COVER SHEATH OF THE DEVICE THAT IS PULLED BACK TO DEPLOY THE DEVICE BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21199643 ↗
• MalfunctionDec 11, 2024Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY DID NOT DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20900940 ↗
• MalfunctionApr 9, 2024Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT BRACHIAL VIA THE LEFT ARM ACCESS, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE DISTAL END OF THE STENT WAS ALLEGEDLY SLIGHTLY OUT OF THE CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19069524 ↗
• MalfunctionDec 16, 2021Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE PROXIMAL OUTER SHEATH ALLEGEDLY SEPARATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13015722 ↗
• MalfunctionJul 14, 2020Positioning Failure; Fracture; Positioning Failure; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION, A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM06080 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE AND FRACTURE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED INJURY. THE MALE PATIENT WAS 64 YEARS OLD AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10272248 ↗
• MalfunctionOct 14, 2019Positioning Failure; Misfire; Positioning Failure; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM06080 ENDOVASCULR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY AND A MISFIRE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9189086 ↗