Fluency® Endovascular Stent Graft FEM09080Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04049519008554), received between Nov 18, 2015 and Feb 16, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 16, 2026Positioning Failure; Fracture

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE FOR INTRAGRAFT VIA THE RIGHT UPPER ARM USING FLUENCY PLUS ENDOVASCULAR STENT GRAFT. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT ALLEGEDLY DID NOT DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24342490 ↗
• MalfunctionJun 15, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY NOT PLACED IN THE EXACT PLACE THAT IT WAS ORIGINALLY PLANNED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14694204 ↗
• MalfunctionMar 28, 2022Premature Activation; Premature Activation

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE INNER CATHETER OF THE DEVICE WAS PROTRUDING THE SHEATH AND THE SYSTEM WAS NOT USED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929201 ↗
• MalfunctionJan 9, 2020Positioning Failure; Retraction Problem; Positioning Problem; Positioning Failure; Retraction Problem; Positioning Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM09080 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, POSITIONING ISSUE, AND RETRACTION PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6)FEMALE PATIENT WAS (B)(6) LB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9570560 ↗
• MalfunctionJul 25, 2017Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE, TO TREAT AN STENOSIS IN THE BRACHIAL CEPHALIC, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM AND THE DELIVERY SYSTEM ALLEGEDLY BROKE. THEREFORE, THE ENDOVASCULAR DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6742564 ↗
• MalfunctionJun 20, 2016Positioning Failure

  IT WAS REPORTED THAT DURING STENTING OF A STENOSIS IN A RIGHT UPPER ARM FISTULA, THE SHEATH OF THE STENT DELIVERY SYSTEM COULD NOT BE PULLED BACK AND THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE AND ANOTHER STENT GRAFT OF THE SAME BRAND WAS USED 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 5735445 ↗
• MalfunctionDec 9, 2015Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED IN THE BASILIC VEIN. THE DEVICE WAS RETRACTED WITHOUT ISSUE AND ANOTHER STENT GRAFT WAS USED 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 5276613 ↗
• MalfunctionNov 18, 2015Positioning Failure

  IT WAS REPORTED THAT DURING PLACEMENT OF THE ENDOVASCULAR STENT GRAFT IN A TOUGH FISTULA, THE STENT GRAFT COULD NOT BE DEPLOYED. THE DEVICE WAS RETRACTED WITHOUT ISSUE. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5234435 ↗