Fluency® Endovascular Stent Graft FEM10060Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 04049519008592), received between Sep 29, 2015 and Jul 27, 2026 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 27, 2026Fracture; Misfire; Malposition of Device; Detachment of Device or Device Component

  On (b)(6) 2026, a 74-year-old male patient underwent treatment for femoral artery stenosis/iliac artery aneurysm via angiography using a Fluency Plus Endovascular Stent Graft at the left upper arm venous graft anastomosis site. During the stent procedure, the Fluency stent failed to fully deploy. The delivery system detached and became loose, resulting in unintended stent movement during the attempted deployment. Additionally, the sheath fractured during the procedure. The patient is stable, and there was no reported patient injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50021161 ↗
• MalfunctionJan 29, 2025Fracture; Defective Component; Fracture; Defective Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, A SPRING WAS ALLEGEDLY POPPED OUT OF THE DELIVERY SYSTEM AFTER SUCCESSFUL DEPLOYMENT OF THE STENT GRAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21263732 ↗
• MalfunctionJan 28, 2025Break; Positioning Failure; Fracture; Break; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE CATHETER ALLEGEDLY COULD NOT BE DEPLOYED. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY FRACTURED NEAR THE METAL PIECE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21261122 ↗
• MalfunctionNov 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE OUTER SLEEVE ALLEGEDLY CAME LOOSE FROM THE HANDLE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629151 ↗
• MalfunctionMar 21, 2022Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT GRAFT FAILED TO DEPLOY. THERE WAS NOT REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839987 ↗
• MalfunctionDec 3, 2021Positioning Failure; Fracture; Positioning Failure; Fracture

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12922370 ↗
• MalfunctionOct 23, 2020Fracture; Misfire; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL FEM10060 ENDOVASCULAR STENT ALLEGEDLY EXPERIENCED PARTIAL DEPLOYMENT AND FRACTURE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. THE PATIENT AGE, WEIGHT AND GENDER WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731530 ↗
• MalfunctionJul 15, 2020Fracture; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE MALFUNCTION INDICATED THAT MODEL FEM10060 ENDOVASCULAR STENT GRAFT WAS ALLEGEDLY EXPERIENCED FRACTURE. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THE EVENT INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE (B)(6) YEAR OLD FEMALE PATIENT WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10276609 ↗
• InjuryNov 21, 2019Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT AFTER A STENT GRAFT PLACEMENT IN A LEFT UPPER ARM FISTULA, THE STENT GRAFT ALLEGEDLY OCCLUDED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HOSPITALIZED AND AN ADDITIONAL DECLOT PROCEDURE WAS REQUIRED TO RESTORE PATENCY. THE PATIENT IS REPORTEDLY STABLE.

  Patient problems: Occlusion

  MAUDE report 9357158 ↗
• MalfunctionMay 20, 2019Positioning Failure; Material Perforation; Positioning Failure; Material Perforation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY FROM THE DELIVERY SYSTEM. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8624607 ↗
• MalfunctionNov 30, 2017Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE INTENDED FOR THE STENOSIS AT THE JUNCTION OF THE RIGHT SUBCLAVIAN VEIN AND THE BRACHIAL CEPHALIC VEIN WITH ACCESS THROUGH THE FISTULA, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED ABOUT FIVE MILLIMETERS AND THE OUTER SHEATH OF THE DELIVERY SYSTEM FRACTURED. 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 7073322 ↗
• MalfunctionMay 17, 2017Difficult or Delayed Positioning; Malposition of Device; Difficult or Delayed Positioning; Malposition of Device

  IT WAS REPORTED THAT DURING THE ATTEMPT TO PLACE THE ENDOVASCULAR STENT GRAFT IN A LEFT UPPER ARM FISTULA FOR TREATMENT OF AN ANEURYSM, THE STENT GRAFT BECAME DIFFICULT TO DEPLOY. DURING THE ATTEMPT TO COMPLETE THE DEPLOYMENT, THE ENDOVASCULAR STENT GRAFT JUMPED AND MISSED THE TARGET LESION COMPLETELY RESULTING IN THE NEED TO USE AN ADDITIONAL STENT TO FINISH THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6572080 ↗
• MalfunctionNov 9, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING PLACEMENT IN A BRACHIAL UPPER ARM FISTULA VIA ACCESS THROUGH THE FOREARM, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. 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 6089071 ↗
• MalfunctionAug 17, 2016Positioning Failure; Difficult to Advance; Positioning Failure; Difficult to Advance

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR TREATMENT OF A CENTRAL VENOUS STENOSIS IN THE BRACHIOCEPHALIC VEIN, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. REPORTEDLY, DIFFICULTIES IN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LESION WERE EXPERIENCED AND THE PROXIMAL END OF THE STENT GRAFT COULD NOT BE PLACED IN A STRAIGHT SECTION OF THE LUMEN PRIOR TO STENT GRAFT DEPLOYMENT AS IT WAS DIFFICULT TO MOVE IT TO THE CORRECT POSITION. 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 5881674 ↗
• MalfunctionApr 19, 2016Positioning Failure; Material Deformation

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT, THE TIP OF THE DELIVERY SYSTEM APPEARED TO BE DEFORMED BUT WAS STILL ATTACHED. THE STENT GRAFT WAS NOT DEPLOYED. 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 5586742 ↗
• MalfunctionDec 17, 2015Positioning Failure; Premature Activation; Retraction Problem

  IT WAS REPORTED THAT THE STENT GRAFT COULD ONLY BE PARTIALLY DEPLOYED. THE INTENDED PLACEMENT SITE WAS THE VENOUS LEFT BASILIC AND DISTAL BRACHIAL OUTFLOW VEIN, AND THE ACCESS SITE WAS THE LEFT GRAFT FOR DIALYSIS. THERE WERE SOME DIFFICULTIES IN RETRACTING THE DELIVERY SYSTEM FROM THE PATIENT. 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 5307305 ↗
• MalfunctionOct 26, 2015Break; Positioning Failure; Fracture

  IT WAS REPORTED THAT THE DELIVERY SYSTEM OF THE ENDOVASCULAR STENT GRAFT SNAPPED IN THE MIDDLE SECTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5177385 ↗
• MalfunctionSep 29, 2015Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED DURING THE PLACEMENT PROCEDURE. REPORTEDLY, THE DEVICE WAS RETRACTED WITHOUT ISSUE AND 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 5110624 ↗