Fluency® Endovascular Stent Graft FEM14040Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 04049519008684), received between Sep 23, 2015 and Apr 2, 2025 — classified as 5 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Material Perforation” (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 25 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2025Break; Positioning Failure; Material Perforation; Misfire; Break; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY NOT DEPLOYED. IT WAS FURTHER REPORTED THAT THE STENT'S BOTH ENDS WAS ALLEGEDLY SNAGGED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21749424 ↗
• MalfunctionMar 17, 2025Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT ARTERY, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THERE WAS ALLEGEDLY PERFORATION OF SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21617732 ↗
• MalfunctionDec 3, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE CEPHALIC VEIN VIA THE RIGHT ARM, THE TIP OF THE STENT ALLEGEDLY BROKE. IT WAS FURTHER REPORTED THAT BROKEN PART OF THE DEVICE WAS ALLEGEDLY RETRIEVED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832903 ↗
• MalfunctionJan 22, 2024Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA THE RIGHT CEPHALIC VEIN, THE STENT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE PARTIALLY OPENED STENT WAS REMOVED FROM THE PATIENT. REPORTEDLY, THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18550616 ↗
• MalfunctionDec 7, 2023Entrapment of Device; Material Perforation; Misfire; Entrapment of Device; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED UPTO TWO CENTIMETERS. IT WAS FURTHER REPORTED THAT DELIVERY SYSTEM ALLEGEDLY GOT CAUGHT ON THE STENT GRAFT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18281375 ↗
• MalfunctionSep 18, 2023Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE SUBCLAVIAN VEIN VIA THE RIGHT ARM FISTULA, THE STENT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT WHEN THE STENT WAS PULLED OUT OF THE PATIENT, IT APPEARED THAT A STRUT WAS STICKING OUT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17764857 ↗
• MalfunctionSep 11, 2023Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY DEPLOYED PARTIALLY BUT IMMEDIATELY STOPPED AND FELT STUCK. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17717389 ↗
• MalfunctionMay 31, 2023Material Perforation; Misfire; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE STENT WAS ALLEGEDLY FOUND TO BE PROTRUDING THE GRAFT MATERIAL UPON REMOVAL FROM THE PATIENT. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17035619 ↗
• MalfunctionNov 30, 2021Material Perforation; Misfire; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN LEFT ARM FISTULA, THE STENT WOULD NOT UNSHEATHE FOR DEPLOYMENT. IT WAS FURTHER REPORTED THAT THE RADIOPAQUE MARKERS WERE PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE STENT STRUT POKED THROUGH THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12889065 ↗
• InjuryNov 1, 2021Break; Material Invagination; Material Perforation; Misfire; Break; Material Invagination; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN RIGHT ARM FISTULA. THE STENT GRAFT DID NOT PROPERLY UNSHEATHE FROM THE CATHETER, AND AFTER THE DEVICE WAS REMOVED FROM THE PATIENT, THE RADIOPAQUE MARKERS WERE ALLEGEDLY PARTIALLY DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12725978 ↗
• MalfunctionJul 20, 2020Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM14040 ENDOVASCULAR STENT GRAFT ALLEGEDLY DEPLOYED PARTIALLY AND EXPERIENCED MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ALLEGED MALFUNCTION HAD PATIENT INVOLVEMENT HOWEVER THERE WERE NO PATIENT CONSEQUENCES. THE AGE, WEIGHT AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10295717 ↗
• InjuryDec 27, 2019Difficult or Delayed Positioning; Malposition of Device; Detachment of Device or Device Component; Difficult or Delayed Positioning; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING DEPLOYMENT, THE HEALTHCARE PROVIDER (HCP) ALLEGEDLY EXPERIENCED SOME RESISTANCE AND THE STENT GRAFT WAS NOT FLOWERING; HOWEVER, THE DELIVERY SYSTEM JUMPED FORWARD AND THE STENT GRAFT DEPLOYED. IT WAS FURTHER REPORTED THAT UPON STENT GRAFT PLACEMENT, THE TIP BROKE OFF AND MIGRATED TO THE LUNG. CURRENT PATIENT STATUS IS UNKNOWN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9526180 ↗
• MalfunctionOct 11, 2019Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9181671 ↗
• MalfunctionApr 1, 2019Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. REPORTEDLY, A NEW DELIVERY SYSTEM WAS USED TO COMPLETED THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470944 ↗
• MalfunctionFeb 7, 2019Break; Malposition of Device; Detachment of Device or Device Component; Break; Malposition of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT INNOMINATE VEIN TO TREAT STENOSIS VIA ACCESS THROUGH A RIGHT UPPER ARM ARTERIOVENOUS FISTULA, UPON DEPLOYMENT THE STENT GRAFT ALLEGEDLY JUMPED AND THE SHEATH MARKER BAND DETACHED AND MIGRATED TO THE LEFT LOWER LUNG LOBE. ANOTHER STENT GRAFT WAS DEPLOYED TO COMPLETELY COVER THE LESION. THE USER FELT A SLIGHT FORCE INCREASE DURING DEPLOYMENT. THE ANATOMY OF THE TRACKING VESSEL WAS WITHOUT APPARENT CALCIFICATION, AND THE PROXIMAL END OF THE STENT GRAFT WAS PLACED IN A STRAIGHT SECTION OF THE LUMEN PRIOR DEPLOYMENT; THE LESION WAS NOT PRE DILATED AND THE USER DID NOT EXPERIENCE DIFFICULTY ADVANCING THE SYSTEM TO THE LESION SITE. FURTHERMORE, THE DETACHED MARKER REMAINS IN THE PATIENT AS THE HEALTHCARE PROFESSIONAL DECIDED IT WOULD NOT CAUSE HARM TO THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8316919 ↗
• MalfunctionMay 16, 2018Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT OF THE SUBCLAVIAN VEIN, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE AND THE STENT GRAFT WAS FOUND TO HAVE PERFORATED THE CATHETER AT THE DISTAL TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7520602 ↗
• MalfunctionApr 13, 2018Material Perforation; Deformation Due to Compressive Stress; Device Operates Differently Than Expected; Material Perforation; Deformation Due to Compressive Stress; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FORESHORTENED AS IT WAS PLACED IN THE CEPHALIC ARCH VIA THE LEFT ELBOW. THEREFORE, A BARE STENT WAS USED OVERLAPPING THE STENT GRAFT TO COVER AN APPROXIMATE 5MM GAP TO COVER THE LESION AND COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7429280 ↗
• MalfunctionMar 27, 2018Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR A STENOSIS WITH ACCESS THROUGH THE A/V FISTULA, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. REPORTEDLY, THE DEVICE WAS REMOVED WITHOUT INCIDENT 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 7375748 ↗
• MalfunctionFeb 13, 2018Material Perforation; Material Perforation

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE WAS IDENTIFIED WITH AN ALLEGED PERFORATION CAUSED BY A STENT STRUT. THEREFORE, THIS DEVICE WAS NOT USED AND EXCHANGED FOR ANOTHER TO PERFORM THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Patient Involvement

  MAUDE report 7267116 ↗
• InjuryOct 10, 2017Break; Migration or Expulsion of Device; Difficult to Remove; Detachment of Device or Device Component; Break; Migration or Expulsion of Device; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON REMOVAL OF THE DELIVERY SYSTEM POST BAREBACK STENT GRAFT DEPLOYMENT NEXT TO THE ARTERIAL ANASTOMOSIS OF THE VEIN OF THE RIGHT UPPER ARM FISTULA, THE TIP OF THE DELIVERY SYSTEM ALLEGEDLY BROKE OFF FROM THE DEVICE AND MIGRATED TO THE PULMONARY ARTERY OF THE LUNG OF THE PATIENT. THE TIP OF THE DELIVERY SYSTEM REMAINED INSIDE THE PATIENT. PATIENT STATUS IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6939295 ↗
• MalfunctionDec 13, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE STENT GRAFT FAILED TO DEPLOY DURING TREATMENT OF A CENTRAL VEIN STENOSIS IN THE LEFT BRACHIOCEPHALIC VEIN. REPORTEDLY, A LOT OF RESISTANCE WAS ENCOUNTERED DURING THE ATTEMPT TO DEPLOY THE SYSTEM. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUES. ANOTHER DEVICE FROM THE SAME BRAND WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6170043 ↗
• InjuryNov 23, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED IN THE SUBCLAVIAN VEIN. REPORTEDLY, THE TIGHT STENOSIS HAD BEEN PRE-DILATED. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00301.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6124055 ↗
• MalfunctionAug 9, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR TREATMENT OF AN IN-STENT RESTENOSIS IN THE RIGHT SUBCLAVIAN VEIN VIA ACCESS THROUGH AN A/V GRAFT, THE ENDOVASCULAR 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 5856382 ↗
• MalfunctionOct 12, 2015Positioning Failure; Difficult to Insert; Material Perforation; Failure to Advance

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT IN THE SUBCLAVIAN VEIN, RESISTANCE WAS FELT AND THEREFORE, THE STENT GRAFT COULD NOT BE RELEASED. IT WAS FURTHER REPORTED THAT THERE WERE SOME DIFFICULTIES IN PASSING THE DELIVERY SYSTEM TIP THROUGH THE PATIENT'S SKIN. THE DEVICE WAS RETRACTED WITHOUT ISSUE AND 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 5143833 ↗
• InjurySep 23, 2015Positioning Failure; Material Perforation

  IT WAS REPORTED THAT DURING PLACEMENT OF THE ENDOVASCULAR STENT GRAFT IN THE SUBCLAVIAN ARTERY WITH ACCESS THROUGH A LOWER ARM GRAFT, THE STENT GRAFT COULD NOT BE DEPLOYED. THE DELIVERY SYSTEM WAS RETRACTED WITHOUT DIFFICULTY AND AFTER REMOVAL, A STENT GRAFT STRUT WAS IDENTIFIED TO BE STICKING OUT OF THE COVER OF THE STENT GRAFT. THE ACCESS SITE WAS CLOSED AND THE PROCEDURE WAS RESCHEDULED TO BE COMPLETED AT A LATER DATE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5096767 ↗