Fluency® Endovascular Stent Graft FEM10080Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 04049519008608), received between Jan 7, 2016 and Jul 15, 2026 — classified as 1 injury, 22 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.

• MalfunctionJul 15, 2026Difficult or Delayed Positioning; Detachment of Device or Device Component

  On (b)(6) 2026, a patient underwent a stent placement procedure using a Fluency Plus Endovascular Stent Graft for the treatment of stenosis at the venous anastomosis via a left upper arm graft. During the procedure, while the stent was being deployed, it was observed that the clear plastic knob on the back of the Tuohy was loose and became disconnected, making stent deployment more difficult. The patient is doing well, with no reported complications during or after the procedure. There was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25822439 ↗
• MalfunctionApr 24, 2026Break; Difficult to Advance

  ON (B)(6) 2026, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING FLUENCY PLUS. REPORTEDLY, FLUENCY DEPLOYED IN THE COMMON ILIAC, RESISTANCE ADVANCING THEY DELIVERY SYSTEM, STENT BROKE IN THE PATIENT, AND THEY HAD TO SNARE OUT PIECES OF THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24979530 ↗
• MalfunctionMar 3, 2026Break; Migration or Expulsion of Device; Malposition of Device; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE BY USING THE FLUENCY STENT SYSTEM. IT WAS REPORTED THAT DURING DEPLOYMENT, THE DEPLOYMENT SYSTEM EXPERIENCED A MECHANICAL FAILURE AND ALLEGEDLY BROKE OFF. DESPITE THE BREAKAGE, THE FLUENCY STENT WAS FULLY DEPLOYED, AND THE DEPLOYMENT SYSTEM WAS REMOVED FROM THE PATIENT WITHOUT COMPLICATION. IT WAS NOTED THAT THE STENT WAS INADVERTENTLY RETRACTED APPROXIMATELY 1TO 2 CM FROM THE INTENDED LANDING ZONE. THE IMPLANTING PHYSICIAN CONFIRMED THAT ALTHOUGH THE FINAL POSITION WAS NOT IDEAL, THE CLINICAL OUTCOME REMAINED ACCEPTABLE. SUBSEQUENT INVESTIGATION INDICATED THAT THE HEMOSTATIC VALVE OF THE TOUHY BORST Y ADAPTER MAY HAVE BEEN EXCESSIVELY LOOSENED, LEADING TO THE VALVE DETACHING DURING THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24493969 ↗
• MalfunctionSep 25, 2025Break; Misfire; Break; Misfire

  ON (B)(6) 2025, A PATIENT UNDERWENT AV FISTULA THROMBECTOMY PROCEDURE. DURING DEPLOYMENT OF THE FLUENCY 10X80, ALLEGEDLY THE STENT BROKE OFF. THE STENT WAS REMOVED COMPLETELY OUT OF THE PATIENT BEFORE IT WAS FULLY DEPLOYED AND A SMALLER DIAMETER FLUENCY WAS USED TO REALIGN A BARE METAL STENT IN OR AROUND THE AXILLA. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23140400 ↗
• MalfunctionMay 21, 2025Break; Positioning Failure; Break; Positioning Failure

  ON (B)(6) 2025, A 75-YEAR-OLD FEMALE PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE USING THE 10MMX80MM FLUENCY PLUS ENDOVASCULAR STENT GRAFT IN UPPER ARM. DURING THE PROCEDURE, THE STENT ALLEGEDLY FAILED TO DEPLOY. IN AN ATTEMPT TO DEPLOY IT MADE AN AUDIBLE NOISE AND IT COULD BE FELT BY THE TECH, THAT IT BROKE. THE DEVICE WAS ABLE TO BE REMOVED FROM THE GRAFT SUCCESSFULLY WITH NO PROBLEMS TO THE PATIENT. A SECOND FLUENCY STENT WAS THEN OPENED AND SUCCESSFULLY PLACED WITH NO ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22058333 ↗
• MalfunctionJul 13, 2024Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE BADLY STENOSED BRACHIAL VEIN VIA THE LEFT UPPER ARM, THE STENT ALLEGEDLY FAILED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736667 ↗
• MalfunctionSep 8, 2023Break; Misfire; Break; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE ARTERIOVENOUS FISTULA, THERE WAS SLIGHT RESISTANCE DURING THE STENT GRAFT DEPLOYMENT ATTEMPT, AND THE STENT WOULD NOT FULLY DEPLOY. IT WAS FURTHER REPORTED THAT FIFTY TO SIXTY PERCENT OF THE STENT GRAFT GOT DEPLOYED. REPORTEDLY, THE CATHETER WAS ALLEGEDLY FRACTURED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17709022 ↗
• MalfunctionAug 25, 2023Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY WOULD NOT DEPLOY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17622215 ↗
• MalfunctionJul 27, 2023Difficult or Delayed Positioning; Fracture; Difficult to Remove; Material Perforation; Misfire; Difficult or Delayed Positioning; Fracture; Difficult to Remove; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING AN INTRA GRAFT STENOSIS STENT PLACEMENT PROCEDURE, STENT GRAFT ALLEGEDLY DID NOT DEPLOY PROPERLY. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY IN REMOVING THE DEPLOYMENT SYSTEM AND ALLEGEDLY BROKE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404669 ↗
• MalfunctionApr 14, 2023Break; Misfire; Break; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY HAD AN ISSUE WHILE DEPLOYING. IT WAS FURTHER REPORTED THAT THE TOP OUTER BLUE BRAIDED PORTION PULLED APART AND SEPARATED LOSING THE OPTION FOR DEPLOYMENT WITH THE PUSH PULL PART. REPORTEDLY, THE STENT GOT TWO TO THREE CENTIMETERS DEPLOYED AND THEN IT WOULD STILL STICK IN THE SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16740612 ↗
• MalfunctionFeb 24, 2023Break; Difficult or Delayed Positioning; Fracture; Misfire; Break; Difficult or Delayed Positioning; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY DIFFICULT TO DEPLOY AT THE LESION SITE TO TREAT STENOSIS AND ANEURYSM IN THE LOWER ARM BASILIC VEIN. IT WAS FURTHER REPORTED THAT, THE DEVICE PULLING MECHANISM ALLEGEDLY BROKE OFF COMPLETELY. REPORTEDLY, THE WHOLE STENT WAS REMOVED OUT OF GRAFT AFTER THE TIP HAS EXPANDED. THE PROCEDURE WAS COMPLETED REPLACING ANOTHER STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16434249 ↗
• MalfunctionJan 20, 2022Positioning Failure; Fracture; Material Perforation; Misfire; Positioning Failure; Fracture; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE THROUGH RIGHT FOREARM, 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 13306878 ↗
• MalfunctionSep 20, 2021Break; Positioning Failure; Retraction Problem; Difficult or Delayed Activation; Break; Positioning Failure; Retraction Problem; Difficult or Delayed Activation

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT STENT WAS ALLEGEDLY DEPLOYED IN SHEATH AND HAD A DIFFICULTY ON REMOVING. REPORTEDLY DEPLOYED MECHANISM WAS CRACKED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12494067 ↗
• MalfunctionJul 15, 2020Misfire; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM10080 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED PARTIAL DEPLOYMENT. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION HAD PATIENT INVOLVEMENT BUT THE PATIENT HAD NO CONSEQUENCES. THE PATIENT'S AGE, GENDER, AND WEIGHT WAS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276612 ↗
• MalfunctionJul 14, 2020Positioning Failure; Misfire; Positioning Failure; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM10080 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE AND MISFIRE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE AGE, WEIGHT AND GENDER OF THE PATIENT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10272857 ↗
• MalfunctionJul 19, 2019Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM10080 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, FRACTURE, AND MISFIRE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE FAILURE TO DEPLOY, FRACTURE, AND MISFIRE INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCE. THE AGE, WEIGHT, AND SEX WERE NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8808580 ↗
• MalfunctionMay 30, 2019Positioning Failure; Retraction Problem; Positioning Failure; Retraction Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE VIA ACCESS THROUGH THE LEFT ARM, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED APPROXIMATELY 5MM. IT WAS FURTHER REPORTED THAT THERE WAS DIFFICULTY RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT. ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8655283 ↗
• MalfunctionAug 7, 2018Positioning Failure; Material Invagination; Detachment of Device or Device Component; Positioning Failure; Material Invagination; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PREPARATION FOR PROCEDURE, UPON OPENING THE PACKAGE, THE DISTAL TIP OF THE ENDOVASCULAR CATHETER DELIVERY SYSTEM WAS IDENTIFIED ALLEGEDLY DETACHED RENDERING THE DEVICE UNUSABLE. REPORTEDLY, ANOTHER DEVICE WAS USED TO PERFORM THE PROCEDURE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7760209 ↗
• MalfunctionMar 21, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR TREATMENT OF AN IN-STENT RESTENOSIS OF A VERY TORTUOUS A/V LOOP GRAFT, STRONG RESISTANCE WAS FELT DURING THE ATTEMPT TO DEPLOY THE ENDOVASCULAR STENT GRAFT AND THE PROXIMAL PART OF THE DELIVERY SYSTEM SHAFT BEGAN TO STRIP. THE DEVICE WAS REMOVED AND ANOTHER ENDOVASCULAR STENT GRAFT WAS USED, BUT HAD THE SAME PROBLEM. THE PROCEDURE WAS FINISHED BY DEPLOYING A BARE METAL STENT AND PROPER FLOW WAS ACHIEVED. 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 6422159 ↗
• MalfunctionMar 21, 2017Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6421950 ↗
• InjuryNov 23, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED IN THE CEPHALIC VEIN FOR TREATMENT OF A BRACHIOCEPHALIC FISTULA VIA ACCESS THROUGH THE FISTULA. REPORTEDLY, THE TIGHT STENOSIS HAD BEEN PRE-DILATED WITH TWO BALLOONS. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00302.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6124056 ↗
• MalfunctionOct 12, 2016Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A SHEATHLESS STENT GRAFT PLACEMENT PROCEDURE FOR TREATMENT OF A PRE-DILATED LEFT SUBCLAVIAN VEIN STENOSIS (THE PATIENT HAD A LEFT UPPER ARM GRAFT), THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. REPORTEDLY, RESISTANCE WAS FELT WHEN TRYING TO RELEASE THE STENT GRAFT. THE DEVICE WAS REMOVED 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 6022175 ↗
• MalfunctionJan 7, 2016Difficult to Advance; Positioning Failure; Retraction Problem; Difficult to Advance

  IT WAS REPORTED THAT THE OUTER CATHETER OF THE ENDOVASCULAR STENT GRAFT WOULD NOT RETRACT; THEREFORE, THE STENT GRAFT ALLEGEDLY WOULD NOT DEPLOY. IT WAS FURTHER REPORTED THAT ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY REPORTED.

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

  MAUDE report 5351330 ↗