Fluency® Endovascular Stent Graft FEM12040Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 04049519008639), received between Dec 2, 2015 and Jan 9, 2026 — classified as 35 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (23 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 25 most recent of 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 9, 2026Entrapment of Device; Material Perforation; Misfire; Activation Failure

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING FLUENCY STENT. DURING THE PROCEDURE THE STENT HAD STRUT STICKING OUT PRE DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24018126 ↗
• MalfunctionMar 25, 2025Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21685669 ↗
• MalfunctionJan 10, 2025Positioning Failure; Material Perforation; Misfire; Material Deformation; Positioning Failure; Material Perforation; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY WOULD NOT DEPLOY. IT WAS FURTHER REPORTED THAT THE TIP OF THE CATHETER WAS ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21126502 ↗
• MalfunctionApr 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE TIP OF THE STENT ALLEGEDLY CAME OFF AND HAD TO BE RECOVERED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19057366 ↗
• MalfunctionMay 15, 2023Positioning Failure; Misfire; Activation Failure; Positioning Failure; Misfire; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE TO TREAT PSEUDOANEURYSM IN THE RIGHT FOREARM ARTERIOVENOUS FISTULA, THE STENT ALLEGEDLY FAILED TO DEPLOY WHEN INSERTED TO CORRECT THE POSITIONING OF ANOTHER STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930600 ↗
• MalfunctionOct 20, 2022Positioning Failure; Fracture; Material Perforation; Misfire; Material Twisted/Bent; Positioning Failure; Fracture; Material Perforation; Misfire; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT SHAFT WAS ALLEGEDLY BENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15637148 ↗
• MalfunctionMay 26, 2022Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE TO TREAT A NARROWING OF THE AV FISTULA IN THE ARM, THE STENT GRAFT FAILED TO DEPLOY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14515495 ↗
• MalfunctionFeb 9, 2022Positioning Failure; Material Perforation; Misfire; Material Deformation; Positioning Failure; Material Perforation; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT IN THE LEFT SUBCLAVIAN VEIN TO TREAT A STENOSIS, THE STENT GRAFT GOT STUCK AND FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13497215 ↗
• MalfunctionJul 14, 2020Break; Entrapment of Device; Detachment of Device or Device Component; Break; Entrapment of Device; Detachment of Device or Device Component

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL FEM12040 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED DETACHMENT, ENTRAPMENT AND BREAK. THIS REPORT WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENTS¿ AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273076 ↗
• MalfunctionApr 14, 2020Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12040 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, MATERIAL PERFORATION AND MISFIRE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. BOTH EVENTS DID INVOLVE PATIENTS WITH NO REPORTED PATIENT INJURY. ONE PATIENT IS (B)(6) YEARS OLD, (B)(6) LBS., AND MALE; HOWEVER, THE SECOND PATIENTS¿ AGE, WEIGHT AND GENDER WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957792 ↗
• MalfunctionApr 14, 2020Material Perforation; Misfire; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12040 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MATERIAL PERFORATION AND MISFIRE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCES. THE PATIENT WAS REPORTED AS A (B)(6) YEAR-OLD FEMALE WEIGHING (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957566 ↗
• MalfunctionJan 14, 2020Material Perforation; Misfire; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL FEM12040 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MATERIAL PERFORATION AND MISFIRED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A 58 YEAR-OLD MALE WEIGHING 175 LB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587433 ↗
• MalfunctionJan 13, 2020Positioning Failure; Material Perforation; Misfire; Material Deformation; Positioning Failure; Material Perforation; Misfire; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12040 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, MATERIAL PERFORATION AND DEFORMATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9583856 ↗
• MalfunctionJan 9, 2020Material Perforation; Misfire; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12040 FLUENCY PLUS ENDOVASCULAR STENT GRAFT WAS ALLEGEDLY EXPERIENCED MISFIRE AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE (B)(6) MALE PATIENT WAS (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9572223 ↗
• MalfunctionOct 14, 2019Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12040 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE 65 YEAR OLD MALE PATIENT WAS 180 LB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9189112 ↗
• MalfunctionOct 14, 2019Difficult or Delayed Positioning; Positioning Failure; Fracture; Difficult or Delayed Positioning; Positioning Failure; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE INFORMATION INDICATED THAT MODEL FEM12040 ENDOVASCULAR STENT GRAFT ALLEGEDLY WAS DIFFICULT TO DEPLOY, FAILED TO DEPLOY, MATERIAL PERFORATION, AND FRACTURED. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187901 ↗
• MalfunctionOct 14, 2019Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12040 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, MISFIRE, AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO PATIENT INJURY. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE AND WEIGHT WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187895 ↗
• MalfunctionOct 14, 2019Material Perforation; Misfire; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12040 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A MISFIRE AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENTS AGE, WEIGHT, AND SEX WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187825 ↗
• MalfunctionJul 18, 2019Material Perforation; Misfire; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL FEM12040 ENDOVASCULAR STENT GRAFT ALLEGED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE FOR AN UPPER ARM GRAFT, THE STENT GRAFT ALLEGEDLY DEPLOYED APPROXIMATELY 1 CM. THEREFORE, THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WHOSE AGE, WEIGHT AND GENDER WERE NOT PROVIDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8805675 ↗
• MalfunctionJul 12, 2019Misfire; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12040. ENDOVASCULAR STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT WAS MALE; HOWEVER, AGE, AND WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8786195 ↗
• MalfunctionJul 12, 2019Positioning Failure; Misfire; Positioning Failure; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12040 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A FAILURE TO DEPLOY AND A MISFIRE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED PATIENT CONSEQUENCE. THE PATIENT WAS REPORTED AS A MALE WEIGHING (B)(6) LBS. THE PATIENT¿S AGE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8785993 ↗
• MalfunctionJun 4, 2018Material Invagination; Positioning Problem; Material Invagination; Positioning Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT OF THE RIGHT UPPER ARM TO TREAT A PREVIOUSLY STENOSED BARE METAL STENT, THE STENT GRAFT SYSTEM ALLEGEDLY COULD NOT ADVANCE THROUGH THE BARE METAL STENT. A SHEATH WAS NOT USED FOR THE STENT GRAFT PLACEMENT. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT GRAFT OF SMALLER SIZE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7567478 ↗
• MalfunctionMay 22, 2018Material Perforation; Misfire; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING PROCEDURE IN A LEFT ARM AV FISTULA TO TREAT A VENOUS STENOSIS, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT AN ALLEGED STRUT PERFORATION ON THE CATHETER WAS IDENTIFIED UNDER FLUOROSCOPY; THEREFORE, THE CATHETER WAS REMOVED WITHOUT INCIDENT FROM THE PATIENT. REPORTEDLY, ANGIOPLASTY WAS PERFORMED WITH A PTA BALLOON RESULTING IN VASCULAR FLOW AND COMPLETION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7535421 ↗
• MalfunctionJan 5, 2018Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE INTENDED FOR THE STENOSIS IN THE INNOMINATE AND SUBCLAVIAN OSTIAL WITH ACCESS THROUGH THE RIGHT UPPER ARM FISTULA, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. REPORTEDLY, THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7168473 ↗
• MalfunctionDec 22, 2017Bent; Positioning Failure; Misfire; Bent; Positioning Failure; Misfire

  IT WAS REPORTED THAT TWO STENT GRAFTS WERE INTENDED TO BE USED FOR A CENTRAL VEIN STENOSIS WITH ACCESS THROUGH THE BRACHIOCEPHALIC VEIN AND ALTHOUGH THE FIRST STENT GRAFT DEPLOYED WITHOUT EVENT, THE SECOND STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED AND THE HANDLE OF THE DELIVERY SYSTEM BENT. REPORTEDLY, THE DEVICE WAS RETRACTED WITHOUT DIFFICULTY AND NO FURTHER TREATMENT WAS REQUIRED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7142668 ↗