Fluency® Endovascular Stent Graft FEM08060Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04049519008493), received between Sep 29, 2015 and Dec 4, 2025 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (16 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 4, 2025Break; Misfire; Detachment of Device or Device Component; Break; Misfire; Detachment of Device or Device Component

  A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT. DURING THE PROCEDURE, THE STENT ALLEGEDLY FAILED TO MISFIRE. IT WAS FURTHER REPORTED THAT THE STENT BROKE AND DETACHED. THERE WERE NO REPORTED PATIENT INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23714005 ↗
• MalfunctionDec 7, 2023Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING AN ARTERIOVENOUS GRAFT STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO DEPLOY FROM THE CATHETER DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18282396 ↗
• MalfunctionJan 2, 2023Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, STENT ALLEGEDLY DEPLOYED PARTIALLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16081949 ↗
• MalfunctionAug 11, 2022Break; Difficult or Delayed Positioning; Entrapment of Device; Material Perforation; Detachment of Device or Device Component; Migration; Break; Difficult or Delayed Positioning; Entrapment of Device; Material Perforation; Detachment of Device or Device Component; Migration

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT TIP ALLEGEDLY BROKEN. IT WAS FURTHER REPORTED THE BROKEN TIP WAS MIGRATED TO LUNG. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15207814 ↗
• MalfunctionMar 2, 2022Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY CRACK NEAR THE HUB. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13648746 ↗
• MalfunctionFeb 17, 2022Misfire; Device-Device Incompatibility; Difficult to Advance; Misfire; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD DEVICE-DEVICE INCOMPATIBILITY. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY HAD PARTIAL DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE STENT WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13547656 ↗
• MalfunctionApr 8, 2020Fracture; Material Perforation; Misfire; Fracture; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM08060 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FRACTURE, MISFIRE, AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A 60 YEAR OLD MALE; WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941633 ↗
• MalfunctionApr 8, 2020Break; Positioning Failure; Material Perforation; Break; Positioning Failure; Material Perforation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM08060 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9941443 ↗
• InjuryOct 29, 2019Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING TREATMENT OF A 90% STENOSIS VIA UPPER RIGHT ARM A/V GRAFT, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY AND THE DELIVERY SYSTEM ALLEGEDLY BROKE (DETAILS UNKNOWN). THEREFORE, THE DEVICE WAS REMOVED WITHOUT ISSUE. REPORTEDLY, THE PATIENT IS BEING RETURNED FOR A SECOND INTERVENTION, AS THERE WAS NO ADDITIONAL DEVICE AVAILABLE TO COMPLETE THE PROCEDURE. THE PATIENT IS CURRENTLY STABLE.

  Patient problems: Injury

  MAUDE report 9251303 ↗
• MalfunctionJan 10, 2019Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN THE CEPHALIC ARCH VIA ACCESS THROUGH THE LOWER FOREARM, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8233786 ↗
• MalfunctionNov 16, 2018Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN A FOREARM LOOP GRAFT, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED APPROXIMATELY 1 MM AND THE OUTER SHEATH CATHETER FRACTURED DISTAL OF THE TUOHY BORST ADAPTER. THE STENT GRAFT WAS RETRIEVED AND THE PROCEDURE WAS CONCLUDED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8077974 ↗
• MalfunctionOct 6, 2017Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN THE A/V GRAFT, THE OUTER SHEATH OF THE DELIVERY SYSTEM ALLEGEDLY BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6925920 ↗
• MalfunctionSep 7, 2017Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM; THEREFORE, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT. REPORTEDLY, ANOTHER ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM WAS USED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6848689 ↗
• MalfunctionJun 1, 2017Positioning Failure; Material Invagination; Material Deformation; Positioning Problem; Positioning Failure; Material Invagination; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A SHEATHLESS STENTING PROCEDURE OF THE CEPHALIC ARCH VIA ACCESS THROUGH THE CEPHALIC VEIN, THE DELIVERY SYSTEM COULD NOT BE ADVANCED TO THE LESION SITE DUE TO AN ALLEGED DAMAGE OF THE DISTAL TIP OF THE DELIVERY SYSTEM. THE DEVICE WAS RETRACTED WITHOUT DIFFICULTIES. THIS WAS THE SECOND DEVICE THAT FAILED DURING THIS PROCEDURE. THE PROCEDURE WAS CALLED OFF BECAUSE NO MORE DEVICES WERE AVAILABLE TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT WITH PATIENT ID # (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6606296 ↗
• InjuryMay 16, 2017Activation Failure; Activation Failure

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE OF THE MIDDLE BASILIC VEIN VIA ACCESS THROUGH AN UPPER ARM FISTULA, THE ENDOVASCULAR STENT GRAFT WAS FOUND TO BE INCOMPLETELY EXPANDED POST DEPLOYMENT. THEREFORE, AN ADDITIONAL STENT WAS PLACED INSIDE THE ENDOVASCULAR STENT GRAFT TO EXPAND IT AND MAINTAIN IT OPEN. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6569290 ↗
• MalfunctionMay 11, 2017Positioning Failure; Material Perforation; Positioning Failure; Material Perforation

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE OF THE BASILIC/BRACHIAL VEIN JUNCTION, THE ENDOVASCULAR STENT GRAFT FAILED TO DEPLOY BECAUSE THE MARKER BANDS BECAME STUCK ON THE DELIVERY SYSTEM AND WERE BARELY STICKING THROUGH (APPROXIMATELY 1 MM OUT OF THE DELIVERY SYSTEM). THERE WAS NEITHER ANY REPORTED DIFFICULTY IN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LESION NOR IN RETRACTING IT FROM THE PATIENT. REPORTEDLY, ANGIOPLASTY WAS PERFORMED INSTEAD FOR SUCCESSFUL COMPLETION OF THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6559616 ↗
• MalfunctionMay 2, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR TREATMENT OF A PSEUDOANEURYSM IN A RIGHT FEMORAL DIALYSIS GRAFT (ARTERIAL SIDE) VIA ACCESS THROUGH THE LEFT UPPER ARM, THE ENDOVASCULAR STENT GRAFT ONLY PARTIALLY DEPLOYED AND DID NOT FULLY RELEASE FROM THE DELIVERY SYSTEM. THEREFORE, THE DEVICE WAS REMOVED WITHOUT INCIDENT AND ANOTHER ENDOVASCULAR STENT GRAFT OF LARGER SIZE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6537157 ↗
• MalfunctionApr 10, 2017Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT FOR TREATMENT OF A PRE-DILATED STENOSIS IN THE OUTFLOW OF AN A/V FOREARM GRAFT VIA ACCESS THROUGH THE FOREARM, RESISTANCE WAS MET AND THE OUTER CATHETER OF THE DELIVERY SYSTEM BROKE NEAR THE HANDLE. THE STENT GRAFT COULD NOT BE DEPLOYED. REPORTEDLY, THERE WAS NO DIFFICULTY IN ADVANCING THE SYSTEM TO OR RETRACTING IT FROM THE TREATMENT SITE BUT FORCE WAS USED TO GO AROUND THE LOOP OF THE FOREARM LOOP GRAFT. REPORTEDLY, THE DELIVERY SYSTEM WAS REMOVED WITHOUT INCIDENT 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

  MAUDE report 6476299 ↗
• MalfunctionMar 15, 2017Break; Difficult to Advance; Activation Failure; Break; Difficult to Advance; Activation Failure

  IT WAS REPORTED THAT DURING A SHEATHLESS STENTING PROCEDURE FOR TREATMENT OF A PRE-DILATED STENOSIS OF THE LEFT ANTECUBITAL AREA IN THE FOREARM NEAR AN ARTERIAL ANASTOMOSIS VIA ACCESS THROUGH THE BRACHIAL ARTERY, THE STENT DELIVERY SYSTEM WAS DIFFICULT TO INSERT THROUGH THE ACCESS SITE. UPON WITHDRAWAL OF THE SYSTEM AFTER STENT GRAFT PLACEMENT, A PIECE OF THE DELIVERY SYSTEM WAS ALLEGEDLY LEFT HANGING OUT OF THE HOLE IN THE ARM. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ANY ISSUES. AS REPORTED, THE DISTAL END OF THE STENT GRAFT DID NOT FULLY EXPAND UPON POST-DILATION; HOWEVER, AS THIS WAS ONLY 1 MM OR LESS THERE WAS NO NEED FOR ANY FURTHER TREATMENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6406706 ↗
• MalfunctionNov 30, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE ENDOVASCULAR STENT GRAFT WOULD NOT DISENGAGE FROM THE DELIVERY SYSTEM CATHETER DURING THE ATTEMPT TO DEPLOY THE STENT GRAFT. 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 6135267 ↗
• MalfunctionSep 5, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING TREATMENT OF A BRACHIOCEPHALIC FISTULA IN THE MID CEPHALIC VEIN THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. THE OUTER SHEATH COULD NOT PULLED BACK EASILY. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES 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 5927532 ↗
• MalfunctionJun 29, 2016Positioning Failure; Retraction Problem; Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING STENTING OF A VENOUS ANASTOMOSIS, THE OUTER SHEATH OF THE DELIVERY SYSTEM COULD NOT BE RETRACTED AND THE 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

  MAUDE report 5758753 ↗
• MalfunctionJun 7, 2016Positioning Failure; Fracture; Material Perforation; Fracture; Material Perforation

  IT WAS REPORTED THAT DURING PLACEMENT OF THE ENDOVASCULAR STENT GRAFT IN THE BASILIC VEIN, THE OUTER CATHETER OF THE DELIVERY SYSTEM BROKE AND THE STENT GRAFT COULD NOT BE DEPLOYED. 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 5703532 ↗
• MalfunctionApr 19, 2016Break; Positioning Failure

  IT WAS REPORTED THAT DURING THE ATTEMPT TO DEPLOY THE ENDOVASCULAR STENT GRAFT IN A CURVED SURGICAL DRAFT BEYOND A CORNER OF A DIALYSIS GRAFT, THE SHAFT OF THE DELIVERY SYSTEM BROKE. REPORTEDLY, THE ENTIRE SYSTEM COULD BE REMOVED WITH THE STENT GRAFT STILL NOT DEPLOYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5586715 ↗
• InjuryJan 27, 2016Malposition of Device; Malposition of Device; Device Operates Differently Than Expected

  IT WAS REPORTED THAT IMMEDIATELY POST DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT IN A BASILIC VEIN FISTULA, THE STENT GRAFT JUMPED 2 - 3 CM. AN ADDITIONAL STENT GRAFT WAS PLACED TO COVER THE ORIGINAL INTENDED LOCATION COMPLETELY. NO PATIENT INJURY WAS REPORTED.

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

  MAUDE report 5393926 ↗