Fluency® Endovascular Stent Graft FEM14120Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 04049519008721), received between Oct 14, 2015 and Sep 29, 2026 — classified as 2 deaths, 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (19 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Positioning Failure; Misfire

  On (b)(6)2026, a patient underwent a stent placement procedure using a Flunecy Plus device for subclavian and recurrent stenosis. Reportedly, the stent did not deploy, resulting in partial deployment misfire of the stent delivery system, with the stent remaining in a partially deployed condition and the outer sheath becoming heavily elongated. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50928448 ↗
• MalfunctionJan 5, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT DEPLOYMENT MECHANISM ALLEGEDLY MALFUNCTIONED AND MISSED THE STENOSIS. IT WAS FURTHER REPORTED THAT THE STENTING WAS ALLEGEDLY DONE IN INCORRECT AREA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452603 ↗
• MalfunctionJun 14, 2023Fracture; Material Perforation; Misfire; Fracture; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT, THE SHEET PORTION OF THE DEVICE WAS ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT THE BLUE SEPARATED AND ONLY SHOWING METAL PORTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17130766 ↗
• 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 16783525 ↗
• MalfunctionApr 4, 2023Fracture; Misfire; Material Deformation; Fracture; Misfire; Material Deformation

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE CATHETER WAS COMPLETELY FRAYED. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674869 ↗
• MalfunctionDec 9, 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 15948108 ↗
• DeathNov 24, 2022Misfire; Material Deformation; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RADIAL VEIN FOR DECLOT TREATMENT, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED FROM THE DELIVERY SYSTEM. REPORTEDLY, THERE WAS DIFFICULTY IN INTRODUCING AND REMOVING THE DELIVERY SYSTEM FROM THE UNKNOWN BRAND AND SIZE INTRODUCER SHEATH. A VASCULAR COVERED STENT GRAFT WAS PLACED TO COMPLETE THE PROCEDURE. HOWEVER, IT WAS FURTHER REPORTED THAT POST PROCEDURE THE PATIENT DECEASED FROM PULMONARY EMBOLISM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15859831 ↗
• DeathNov 24, 2022Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RADIAL VEIN FOR DECLOT TREATMENT, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED FROM THE DELIVERY SYSTEM. REPORTEDLY, THERE WAS DIFFICULTY IN INTRODUCING AND REMOVING THE DELIVERY SYSTEM FROM THE UNKNOWN BRAND AND SIZE INTRODUCER SHEATH. A VASCULAR COVERED STENT GRAFT WAS PLACED TO COMPLETE THE PROCEDURE. HOWEVER, IT WAS FURTHER REPORTED THAT POST PROCEDURE THE PATIENT DECEASED FROM PULMONARY EMBOLISM.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15859823 ↗
• MalfunctionJul 11, 2022Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method; Misfire; Malposition of Device; Difficult or Delayed Positioning; Improper or Incorrect Procedure or Method; Misfire; Malposition of Device

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY STENT PLACEMENT PROCEDURE IN THE LEFT ILIAC ARTERY, THE STENT OUTER SHEATH ALLEGEDLY STRETCHED AND FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT PHYSICIAN USED TO CUT THE OUTER SHEATH AND DE SHEATHED. REPORTEDLY STENT WAS DEPLOYED AND AN ANOTHER STENT WAS REQUIRED TO COVER AN AREA MISSED DUE TO MALFUNCTION. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14974402 ↗
• MalfunctionOct 23, 2020Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM14120 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE, MISFIRE AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731158 ↗
• MalfunctionJan 14, 2020Misfire; Misfire

  THIS REPORT SUMMARIZES TWO MALFUNCTIONS. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM14120. ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MISFIRE. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE TWO EVENTS, BOTH INVOLVED PATIENTS WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR BOTH PATIENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586570 ↗
• MalfunctionOct 14, 2019Material Perforation; Misfire; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM14120 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED PARTIAL DEPLOYMENT AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE A PATIENT WITH NO PATIENT INJURY. THE PATIENT AGE, GENDER, AND WEIGHT WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188763 ↗
• MalfunctionApr 13, 2018Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY IN THE LEFT SUBCLAVIAN VEIN VIA THE LEFT BASILICA VEIN ACCESS. THERE WAS NO REPORTED DIFFICULTY IN REMOVING THE DEVICE FROM THE PATIENT. REPORTEDLY, ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429284 ↗
• MalfunctionFeb 15, 2018Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR AN OCCLUSION IN THE ILIAC ARTERY, THE OUTER SHEATH OF THE CATHETER ALLEGEDLY FRACTURED AND THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. REPORTEDLY, THE DEVICE AND THE DELIVERY SYSTEM WERE REMOVED WITHOUT INCIDENT AND THE PROCEDURE WAS CONCLUDED WITHOUT ANY DEVICE IMPLANTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7275122 ↗
• MalfunctionMay 11, 2017Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED IN THE LEFT UPPER ARM AND THAT EXCESSIVE FORCE WAS USED IN AN UNSUCCESSFUL ATTEMPT TO DEPLOY THE STENT GRAFT RESULTING IN THE FRACTURE OF THE OUTER CATHETER. THERE WAS NO REPORTED DIFFICULTY IN RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT. ANOTHER DEVICE WAS USED FOR SUCCESSFUL COMPLETION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559626 ↗
• MalfunctionJul 25, 2016Fracture

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT IN THE CEPHALIC ARCH, THE OUTER CATHETER OF THE DELIVERY SYSTEM FRACTURED. THE STENT GRAFT COULD BE DEPLOYED MANUALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5818936 ↗
• InjuryJun 22, 2016Positioning Failure

  IT WAS REPORTED THAT DURING STENTING OF A RIGHT UPPER ARM FISTULA VIA UPPER ARM ACCESS, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED AND THREE STENT GRAFTS OF THE SAME BRAND BUT SMALLER SIZE WERE USED INSTEAD TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00172 AND 9681442-2016-00173.

  Patient problems: No Consequences Or Impact To Patient; Vascular System (Circulation), Impaired

  MAUDE report 5741803 ↗
• InjuryJun 22, 2016Positioning Failure

  IT WAS REPORTED THAT DURING STENTING OF A RIGHT UPPER ARM FISTULA VIA UPPER ARM ACCESS, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. THE DEVICE WAS REMOVED AND THREE STENT GRAFTS OF THE SAME BRAND BUT SMALLER SIZE WERE USED INSTEAD TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00172 AND 9681442-2016-00174.

  Patient problems: No Known Impact Or Consequence To Patient; Vascular System (Circulation), Impaired

  MAUDE report 5741696 ↗
• MalfunctionApr 26, 2016Positioning Failure

  IT WAS REPORTED THAT AFTER THE FIRST ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM FAILED TO BE DEPLOYED, THIS DEVICE WAS USED ALSO UNSUCCESSFULLY. THE DELIVERY SYSTEM WAS REPORTED TO BE LOCKED-UP AND THE STENT GRAFT COULD NOT BE DEPLOYED. A THIRD STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00117.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5608206 ↗
• MalfunctionApr 21, 2016Positioning Failure; Fracture; Material Separation; Fracture

  IT WAS REPORTED THAT DURING STENT DEPLOYMENT, EXCESSIVE DEPLOYMENT FORCE WAS ENCOUNTERED RESULTING IN THE OUTER CATHETER OF THE DELIVERY SYSTEM TO BE SEPARATED. THE DEVICE WAS REMOVED AND ANOTHER STENT GRAFT WAS ATTEMPTED TO BE DEPLOYED UNSUCCESSFULLY. A THIRD STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5596930 ↗
• MalfunctionApr 7, 2016Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. ANOTHER STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5554680 ↗
• MalfunctionMar 29, 2016Positioning Failure; Positioning Failure; Premature Activation

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT PARTIALLY DEPLOYED. ANOTHER VASCULAR STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO ADDITIONAL TREATMENT WAS REQUIRED. NO PATIENT INJURY WAS REPORTED. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00090.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5533690 ↗
• MalfunctionJan 26, 2016Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. ANOTHER STENT GRAFT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5390134 ↗
• MalfunctionNov 5, 2015Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR TREATMENT OF AN ANEURYSM IN THE UPPER RIGHT ARM, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED ANY FURTHER AFTER BEING RELEASED 1/4. THE DELIVERY SYSTEM COULD BE REMOVED WITHOUT ISSUE. ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 5203815 ↗
• MalfunctionNov 5, 2015Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR TREATMENT OF AN ANEURYSM IN THE UPPER RIGHT ARM, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. THE DELIVERY SYSTEM WAS RETRACTED FROM THE PATIENT WITHOUT DIFFICULTY. 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 5203814 ↗