Fluency® Endovascular Stent Graft FEM08120Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 04049519008523), received between Mar 4, 2016 and Apr 13, 2026 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (8 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 13, 2026Positioning Failure; Misfire

  ON (B)(6) 2026, A PATIENT UNDERWENT ANGIOPLASTY STENT PLACEMENT PROCEDURE USING FLUENCY PLUS ENDOVASC STENT GRAFT. DURING THE PROCEDURE, IT WAS NOTICED THAT THE FLUENCY 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 24856543 ↗
• MalfunctionAug 31, 2024Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DELIVERY SYSTEM ALLEGEDLY SEEMED TO BE STUCK WHEN ATTEMPTING TO REMOVE THE SHEATH. IT WAS FURTHER REPORTED THAT MORE FORCE THAN USUAL WAS ALLEGEDLY REQUIRED TO REMOVE THE SHEATH. REPORTEDLY, UPON REMOVAL, THE TIP OF THE DELIVERY SYSTEM WAS FOUND TO BE SEPARATED FROM THE REST OF THE SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20113841 ↗
• MalfunctionApr 21, 2023Misfire; Misfire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16789872 ↗
• MalfunctionOct 17, 2022Positioning Failure; Misfire; Difficult to Advance; Positioning Failure; Misfire; Difficult to Advance

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15613759 ↗
• MalfunctionOct 27, 2020Positioning Failure; Misfire; Positioning Failure; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM08120 FLUENCY PLUS ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY STENT AND PARTIAL DEPLOYMENT OF STENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE (B)(6) YEAR OLD MALE WEIGHS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10741143 ↗
• MalfunctionApr 9, 2020Positioning Failure; Misfire; Positioning Failure; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM08120 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED DEPLOYMENT ISSUES AND MISFIRE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENTS IS A (B)(6) YEAR OLD FEMALE WEIGHING (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9943758 ↗
• MalfunctionSep 14, 2018Misfire; Misfire

  IT WAS REPORTED THAT THE STENT GRAFT ALLEGEDLY WOULD NOT FULLY DEPLOY IN A VENOUS GRAFT. REPORTEDLY, ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7877585 ↗
• MalfunctionMay 8, 2018Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A LOWER LEFT ARM A/V GRAFT PROCEDURE, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. THEREFORE, THE CATHETER WAS REMOVED WITHOUT INCIDENT. THERE WAS NO REPORTED CALCIFICATION NOR TORTUOUS PATH WITHIN THE VESSEL. REPORTEDLY, ANOTHER ENDOVASCULAR STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7496617 ↗
• InjuryApr 13, 2018Hole In Material; Leak/Splash; Occlusion Within Device; Hole In Material; Leak/Splash; Occlusion Within Device

  IT WAS REPORTED THAT A STENT GRAFT WAS DEPLOYED TO COVER UP AN EXTRAVASATION OF THE CEPHALIC ARCH; HOWEVER, A HOLE WAS ALLEGEDLY IDENTIFIED ON THE COATING OF THE STENT GRAFT AND CONTRAST WAS SEEN LEAKING FROM THE VESSEL WHERE THE STENT GRAFT WAS PLACED. IT WAS FURTHER REPORTED THAT THE GUIDEWIRE WAS SEEN PROTRUDING THROUGH THE STENT GRAFT. THE PATIENT RETURNED TWO DAYS LATER AND THE EPTFE ALLEGEDLY HAD TORN AND CREATED A FLAP, CAUSING THROMBUS WITHIN THE STENT GRAFT. THIS RESULTED IN ANOTHER STENT GRAFT DEPLOYMENT INSIDE OF THE PREVIOUS STENT GRAFT, OVERLAPPING TECHNIQUE TO OPEN THE VESSEL. THE PROCEDURE WAS CONCLUDED AND HE PATIENT WAS REPORTED AS STABLE.

  Patient problems: Thrombus

  MAUDE report 7430943 ↗
• MalfunctionOct 23, 2017Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING THE STENT GRAFT DEPLOYMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT AND REPLACED WITH ANOTHER IN ORDER TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6970678 ↗
• MalfunctionFeb 21, 2017Break; Positioning Failure; Fracture; Activation, Positioning or Separation Problem; Break; Positioning Failure; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED ANY FURTHER AFTER BEING PARTIALLY RELEASED DURING A STENTING PROCEDURE FOR TREATMENT OF A PRE-DILATED LESION IN THE BASILIC VEIN. REPORTEDLY, THE USER WAS ABLE TO GRAB THE PATIENT ON THE ARM AND HOLD THE STENT GRAFT IN PLACE WHILE REMOVING THE DELIVERY SYSTEM SO THAT THE STENT GRAFT COULD BE FULLY DEPLOYED IN THE PATIENT'S BODY. THE INNER CATHETER FRACTURED DURING REMOVAL OF THE DELIVERY SYSTEM BUT COULD BE COMPLETELY REMOVED WITHOUT ANY FURTHER INTERVENTION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6345766 ↗
• MalfunctionAug 11, 2016Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT IN AN EXTREMELY NARROWED CEPHALIC VEIN VIA ACCESS THROUGH THE LEFT ARM, THE OUTER SHEATH OF THE DELIVERY SYSTEM FRACTURED. ANOTHER ENDOVASCULAR 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 5868071 ↗
• MalfunctionMar 4, 2016Material Separation

  IT WAS REPORTED THAT A PLASTIC PIECE JUST FELL APART UPON LOOSENING THE TUOHY. AS REPORTED, THIS HAPPENED WHILE THE DEVICE WAS INSERTED INTO THE PATIENT. THE DEVICE WAS TAKEN OUT OF THE PATIENT AND THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE OF THE SAME BRAND AND TYPE. AS REPORTED THE INDICATION FOR THE STENT GRAFT PLACEMENT WAS A SIGNIFICANT RESIDUAL STENOSIS OF A VENOUS ANASTAMOSIS OF A LEFT ARM GRAFT. THE STENT GRAFT WAS NOT PLACED ACROSS A TIGHT BEND. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: Stenosis

  MAUDE report 5480737 ↗