Fluency® Endovascular Stent Graft FEM10120Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 04049519008622), received between Mar 9, 2016 and Feb 17, 2026 — classified as 4 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Misfire” (27 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 39 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 17, 2026Fracture; Misfire

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE FLUENCY DEVICE. THE DEVICE WAS PREPARED IN THE STANDARD MANNER AND ADVANCED TO THE INTENDED POSITION. DEPLOYMENT WAS INITIATED; HOWEVER, THE DEVICE WAS UNABLE TO COMPLETE THE DEPLOYMENT PROCESS. SIGNIFICANT PULLING FORCE WAS APPLIED IN AN ATTEMPT TO ACHIEVE FULL DEPLOYMENT, DURING WHICH THE DEVICE FRACTURED. THE DEVICE WAS SUBSEQUENTLY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24361886 ↗
• MalfunctionAug 22, 2024Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE TORTUROUS STENOTIC VESSEL VIA THE RIGHT FEMORAL VEIN ACCESS AND FROM THE FISTULA ITSELF, THE DELIVERY SYSTEM WAS ALLEGEDLY STRETCHED AND TORE IN THE MIDDLE DURING AN ALLEGED PARTIAL DEPLOYMENT OF THE STENT. REPORTEDLY, THE DOCTOR WAS ABLE TO TAKE OUT THE STENT SUCCESSFULLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20028394 ↗
• MalfunctionJun 21, 2024Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT ARM FISTULA, THE STENT ALLEGEDLY GOT STUCK HALFWAY THROUGH THE DEPLOYMENT. REPORTEDLY, THE STENT WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING THREE COVERED STENTS TO COVER THE DISTANCE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19584403 ↗
• MalfunctionFeb 14, 2024Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE BRACHIAL CEPHALAD VEIN VIA THE BRACHIAL VEIN ACCESS, THE DEVICE 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 18704710 ↗
• MalfunctionFeb 5, 2024Break; Positioning Failure; Fracture; Misfire; Break; Positioning Failure; Fracture; Misfire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18638208 ↗
• MalfunctionNov 20, 2023Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, ONE-THIRD OF THE STENT WAS DEPLOYED AND THEN THE STENT WOULD NOT BE DEPLOYED ANYMORE. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18169043 ↗
• MalfunctionSep 5, 2023Positioning Failure; Misfire; Positioning Failure; Misfire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17681125 ↗
• MalfunctionJul 10, 2023Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT CEPHALIC ARCH VIA LEFT UPPER ARM FISTULA, PHYSICIAN ALLEGEDLY FELT LOT OF PRESSURE TO DEPLOY THE DEVICE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17285071 ↗
• MalfunctionJun 9, 2023Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR HIGH GRADE STENOSIS VIA ARM FISTULA, THE STENT GRAFT DEPLOYED NORMALLY FOR TWO CENTIMETER THEN ALLEGEDLY STOPPED DEPLOYING ALONG WITH INCREASED RESISTANCE. IT WAS FURTHER REPORTED THAT THE STENT GRAFT WAS ALLEGEDLY BROKEN NEAR THE BLUE PLASTIC OF THE DEPLOYMENT APPARATUS. REPORTEDLY THE STENT GRAFT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17096273 ↗
• MalfunctionJun 9, 2023Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR HIGH GRADE STENOSIS VIA ARM FISTULA, THE STENT GRAFT DEPLOYED NORMALLY FOR SIXTY MILLIMETER THEN ALLEGEDLY STOPPED DEPLOYING ALONG WITH INCREASED RESISTANCE. IT WAS FURTHER REPORTED THAT THE STENT GRAFT WAS ALLEGEDLY BROKEN NEAR THE BLUE PLASTIC OF THE DEPLOYMENT APPARATUS. REPORTEDLY THE STENT GRAFT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17096271 ↗
• MalfunctionMay 25, 2023Positioning Failure; Misfire; Positioning Failure; Misfire

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17001794 ↗
• MalfunctionApr 21, 2023Misfire; Material Deformation; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN CEPHALIC SUBCLAVIAN AREA VIA FISTULA ARM, AREA NEAR HUB ALLEGEDLY BEGAN TO STRETCH. IT WAS FURTHER REPORTED THAT THE DEVICE 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 16783529 ↗
• MalfunctionNov 15, 2022Fracture; Misfire; Detachment of Device or Device Component; Material Deformation; Fracture; Misfire; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY CAME APART. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15795816 ↗
• MalfunctionOct 21, 2022Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT 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 15649121 ↗
• MalfunctionMay 23, 2022Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE THROUGH INTEGRATED BASILIC VEIN, THE STENT ALLEGEDLY HAD PARTIAL DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE STENT DELIVERY SYSTEM WAS REMOVED THROUGH THE SHEATH AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14467900 ↗
• MalfunctionApr 12, 2022Positioning Failure; Misfire; Positioning Failure; 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 14080800 ↗
• MalfunctionSep 16, 2021Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH THE AV FISTULA TO TREAT THE MID CEPHALIC VEIN STENOSIS, THE STENT ALLEGEDLY PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12479804 ↗
• MalfunctionJul 17, 2020Difficult or Delayed Positioning; Fracture; Misfire; Difficult or Delayed Positioning; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM10120 ENDOVASCULAR STENT GRAFT ALLEGED DIFFICULT TO DEPLOY, MISFIRE, SHEATH FRACTURE AND PARTIAL DEPLOYMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE MALE PATIENT'S AGE AND WEIGHT WERE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10289548 ↗
• MalfunctionJul 15, 2020Positioning Failure; Fracture; Positioning Failure; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM10120 ENDOVASCULAR STENT GRAFT SYSTEM ALLEGEDLY EXPERIENCED FAILED TO DEPLOY AND SHEATH FRACTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE MALE PATIENT IS (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276616 ↗
• MalfunctionJul 14, 2020Fracture; Misfire; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL FEM10120 ENDOVASCULAR STENT GRAFT ALLEGEDLY MISFIRED AND FRACTURED. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. A 49 YEAR OLD MALE PATIENT WEIGHS 167 LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273069 ↗
• MalfunctionApr 13, 2020Positioning Failure; Misfire; Positioning Failure; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM10120 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MISFIRE AND POSITIONING FAILURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9955680 ↗
• MalfunctionApr 9, 2020Break; Misfire; Break; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL FEM10120, ENDOVASCULAR STENT GRAFT, ALLEGEDLY EXPERIENCED A BREAK AND A MISFIRE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9944301 ↗
• MalfunctionJan 13, 2020Fracture; Misfire; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM10120. ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FRACTURE AND MISFIRE. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT DID INVOLVE PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS (B)(6) YEARS OF AGE, THE WEIGHT IS (B)(6) LBS; HOWEVER, THE GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9583852 ↗
• MalfunctionOct 15, 2019Failure to Reset; Misfire; Material Deformation; Failure to Reset; Misfire; Material Deformation

  THIS REPORT SUMMARIZES ONE (1) MALFUNCTION EVENT. A REVIEW OF THE EVENT INDICATED THAT MODEL FEM10120 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION, FRACTURED, MISFIRED, AND HAD RETRACTION PROBLEMS. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENTS GENDER, AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9192289 ↗
• MalfunctionSep 13, 2019Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING STENT GRAFT PLACEMENT, THE STENT FAILED TO DEPLOY AND THE PROCEDURE WAS COMPLETED WITH A NEW DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9050819 ↗