Fluency® Endovascular Stent Graft FEM08040Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04049519008486), received between Sep 30, 2015 and Dec 12, 2025 — classified as 5 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (14 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Positioning Failure; Material Separation; Positioning Failure; Material Separation

  A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING FLUENCY PLUS STENT. IT WAS REPORTED THAT THE FLUENCY DID NOT DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23787762 ↗
• MalfunctionMar 3, 2023Obstruction of Flow; Activation Failure; Obstruction of Flow; Activation Failure

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE FOR THE LEFT UPPER ARM LOOP GRAFT REPAIR OF ENLARGING ANEURYSM, THE STENT ALLEGEDLY HAD OBSTRUCTION OF FLOW. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478580 ↗
• MalfunctionOct 21, 2022Positioning Failure; Misfire; Detachment of Device or Device Component; Positioning Failure; Misfire; Detachment of Device or Device Component

  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 15646191 ↗
• MalfunctionMar 16, 2022Break; Failure to Advance; Device-Device Incompatibility; Break; Failure to Advance; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN ATTEMPT TO TREAT A SUBCLAVIAN STENOSIS THROUGH A SHEATH LESS ACCESS SITE, THE DELIVERY SYSTEM BECAME ALLEGEDLY STUCK ON THE GUIDEWIRE AND WAS UNABLE TO FURTHER ADVANCE. REPORTEDLY, THE DEVICE WAS REMOVED CAUSING A LOST OF ACCESS. ANOTHER DEVICE WAS USED TO REGAIN ACCESS AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13789967 ↗
• MalfunctionJan 18, 2022Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE OUTER CATHETER ALLEGEDLY FRACTURED AND STENT GRAFT COULD NOT BE 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 13278712 ↗
• MalfunctionOct 22, 2021Positioning Problem; Positioning Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT IN THE UPPER ARM FISTULA, THE DEVICE ALLEGEDLY WOULD NOT ADVANCE INTO THE FISTULA. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12681882 ↗
• MalfunctionAug 15, 2021Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE TIP OF THE STENT ALLEGEDLY RUPTURED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12322339 ↗
• MalfunctionOct 14, 2019Material Perforation; Misfire; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM08040 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A MISFIRE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT WAS REPORTED AS A MALE WEIGHING 150 LBS; THE PATIENT'S AGE WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187837 ↗
• 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 FEM08040 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 FEMALE AND THE AGE AND WEIGHT WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9187832 ↗
• InjuryMay 31, 2018Break; Fracture; Detachment of Device or Device Component; Break; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A RIGHT UPPER EXTREMITY FISTULOGRAM, ANGIOPLASTY OF VENOUS OUTFLOW STENOSIS, MANAGEMENT OF PSEUDOANEURYSM, AND PLACEMENT OF STENT; WHEN DEPLOYING THE STENT GRAFT A RADIOPAQUE MARKER ALLEGEDLY DETACHED AND MIGRATED THROUGH THE PATIENT'S VEIN THROUGH THE SUPERIOR VENA CAVA AND INTO THE LUNG (PATIENT'S LEFT LOWER LOBE PULMONARY ARTERY). IT WAS FURTHER REPORTED THAT THE HEALTH CARE PROVIDER INITIALLY ATTEMPTED TO SNARE THE SEGMENT UNSUCCESSFULLY. THEREFORE, THE SEGMENT WAS LEFT IN PLACE AS THE RISK FOR RETRIEVAL OUT WEIGHTED THE BENEFITS; SO, NO FURTHER RADIOPAQUE MARKER RETRIEVAL INTERVENTION WAS PERFORMED. REPORTEDLY, ANOTHER ENDOVASCULAR STENT GRAFT CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT IS REPORTEDLY DOING WELL.

  Patient problems: Device Embedded In Tissue or Plaque; No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7559067 ↗
• MalfunctionMay 15, 2017Break; Positioning Failure; Break; Positioning Failure

  IT WAS REPORTED THAT DURING PLACEMENT OF THE ENDOVASCULAR STENT GRAFT FOR TREATMENT OF A STENOSIS IN THE LEFT BASILIC VEIN VIA ACCESS THROUGH AN A/V FISTULA, THE STENT GRAFT COULD NOT BE DEPLOYED. 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 6567002 ↗
• MalfunctionMay 15, 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. ANOTHER STENT GRAFT WAS USED AND FAILED WITH THE SAME ISSUE. AFTER THE FAILURE TO INSERT THE SECOND DELIVERY SYSTEM INTO THE PATIENT, 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 6566999 ↗
• InjuryMay 2, 2017Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT FOR TREATMENT OF A PRE-DILATED A/V ACCESS GRAFT IN THE LEFT MID/UPPER ARM WITH NORMAL EFFORT AND WITHOUT ANY RESISTANCE, IT WAS NOTICED THAT THE RADIOPAQUE MARKER OF THE DELIVERY SYSTEM HAD COME OFF AND REMAINED ON THE DISTAL END OF THE STENT GRAFT. IN AN EFFORT TO CAPTURE THE DETACHED MARKER, AN ATTEMPT WAS MADE TO PASS A BALLOON THROUGH, WITH UNSUCCESSFUL RESULT AS THE BALLOON DID NOT FIT THROUGH THE END. THEREFORE, THE ACCESS WAS FASTENED AND A PERM CATHETER WAS PLACED FOR ACCESS. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 6537109 ↗
• InjuryApr 4, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD ONLY BE DEPLOYED HALFWAY DURING TREATMENT OF A SMALL EXTRAVASATION OF THE LEFT ARM. THE DELIVERY SYSTEM WAS REMOVED AND NO OTHER DEVICE WAS USED. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT CONCERNING PATIENT ID # (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6456909 ↗
• MalfunctionApr 4, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD ONLY BE DEPLOYED HALFWAY DURING TREATMENT OF A SMALL EXTRAVASATION OF THE LEFT ARM. THE DELIVERY SYSTEM WAS REMOVED AND ANOTHER DEVICE OF THE SAME BRAND WAS USED OVER THE SAME ACCESS BUT THE SAME ISSUE OCCURRED. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT CONCERNING PATIENT (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6456907 ↗
• MalfunctionJan 10, 2017Positioning Failure; Fracture; Material Perforation; Positioning Failure; Fracture; Material Perforation

  IT WAS REPORTED THAT DURING STENTING OF AN UPPER ARM GRAFT VIA ACCESS THROUGH THE CEPHALIC VEIN, THE ENDOVASCULAR STENT GRAFT BEGAN TO DEPLOY AND WHEN THE DELIVERY SYSTEM WAS BEING PULLED BACK FURTHER IT GOT STUCK. THE USER SNAPPED THE SHAFT OF THE DELIVERY SYSTEM AND REMOVED THE ENTIRE SYSTEM. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6236125 ↗
• InjuryAug 18, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED IN A CLOTTED UPPER ARM VEIN DIALYSIS GRAFT. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES. NO OTHER STENT GRAFT WAS USED. THE DIALYSIS GRAFT WAS ABANDONED AND A TUNNEL CATHETER WAS PLACED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5885233 ↗
• InjuryAug 16, 2016Difficult or Delayed Positioning; Entrapment of Device; Malposition of Device; Difficult or Delayed Positioning; Entrapment of Device; Malposition of Device

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT WAS USED TO COVER A STENOSIS IN THE FEMORAL VEIN IN THE OUTFLOW OF A LEG GRAFT AS A PREVIOUSLY PLACED STENT GRAFT HAD MIGRATED TO THE OUTFLOW VEIN. REPORTEDLY, DIFFICULTIES WERE EXPERIENCED DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT. SUBSEQUENTLY, A PTA BALLOON WAS USED FOR POST-DILATION AND THE TIP OF THE BALLOON CAUSED THE ENDOVASCULAR STENT GRAFT TO MOVE FORWARD. AN ANGIOPLASTY WAS PERFORMED BY USING THE SAME PTA BALLOON TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5878282 ↗
• MalfunctionApr 20, 2016Positioning Failure

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5590763 ↗
• MalfunctionMar 30, 2016Use of Device Problem; Failure to Advance; Material Deformation; Use of Device Problem; Failure to Advance; Material Deformation; Mechanical Jam

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT GOT STUCK AFTER AN ATTEMPT TO BE DEPLOYED IN AN UPPER ARM DIALYSIS GRAFT. 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 5534889 ↗
• MalfunctionMar 10, 2016Positioning Failure; Fracture; Bent; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING PLACEMENT OF THE VASCULAR STENT IN A RIGHT ARM FISTULA, THE OUTER CATHETER OF THE DELIVERY SYSTEM WAS DISCOVERED TO BE BENT. THE VASCULAR STENT COULD NOT BE RELEASED. THE DEVICE WAS EXCHANGED OVER THE GUIDE WIRE FOR ANOTHER STENT GRAFT THAT COULD BE DEPLOYED SUCCESSFULLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5492533 ↗
• MalfunctionNov 19, 2015Positioning Failure; Material Perforation

  IT WAS REPORTED THAT DURING PLACEMENT OF THE ENDOVASCULAR STENT GRAFT IN A TOUGH FISTULA, THE STENT GRAFT COULD NOT BE DEPLOYED. THE DEVICE WAS RETRACTED WITHOUT ISSUE. ANOTHER STENT 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 5236314 ↗
• MalfunctionSep 30, 2015Positioning Failure; Device-Device Incompatibility; Difficult to Advance

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED AFTER BEING ADVANCED TO THE TREATMENT SITE WITH SOME DIFFICULTIES. THE DEVICE WAS RETRACTED WITHOUT ISSUE AND ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5112815 ↗