Fluency® Endovascular Stent Graft FEL10080Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04049519008257), received between Jun 6, 2016 and Mar 19, 2025 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 19, 2025Break; Fracture; Misfire; Break; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE BRACHIAL VEIN STENOSIS VIA LEFT UPPER ARM, THE STENT WAS ALLEGEDLY PARTIALLY DEPLOYED ABOUT TWO CENTIMETERS. IT WAS FURTHER REPORTED THAT THE DURING DEPLOYMENT, THE BLUE SHEATH BROKE AND WAS STUCK AND WERE UNABLE TO GET IT TO RETRACT TO UNCOVER STENT FULLY. THE STENT WAS REMOVED INTACT SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21640729 ↗
• MalfunctionApr 22, 2024Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE AXILLARY VEIN THROUGH THE LEFT UPPER EXTREMITY, THE FRONT OF THE STENT STARTED TO DEPLOY, BUT THE DEPLOYMENT ALLEGEDLY DID NOT FUNCTION PROPERLY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19150293 ↗
• MalfunctionAug 27, 2018Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILED TO DEPLOY DURING TREATMENT FOR A VENOUS OUTFLOW STENOSIS IN THE ARM (BELOW ELBOW). REPORTEDLY, THE DEVICE WAS REMOVED WITHOUT ISSUE FROM THE PATIENT. ANOTHER ENDOVASCULAR STENT GRAFT CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7821120 ↗
• MalfunctionOct 9, 2017Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY FRACTURED WHEN THE HEALTH CARE PROVIDER WAS ATTEMPTING TO DEPLOY THE STENT GRAFT IN THE LEFT INTERNAL ILIAC ARTERY. IT WAS FURTHER REPORTED THAT THE STENT GRAFT PARTIALLY DEPLOYED ABOUT A QUARTER FROM THE DELIVERY SYSTEM BEFORE THE OUTER CATHETER SHEATH FRACTURED. REPORTEDLY, THE DELIVERY SYSTEM WITH THE STENT GRAFT WAS REMOVED WITHOUT INCIDENT AND REPLACE WITH ANOTHER TO COMPLETE THE PROCEDURE. THE PATIENT WAS HEMODYNAMICALLY STABLE AT THE CONCLUSION OF THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6933276 ↗
• MalfunctionAug 9, 2016Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING DEPLOYMENT, THE ENDOVASCULAR STENT GRAFT ALLEGEDLY WOULD NOT DISENGAGE FROM THE CATHETER. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT WITHOUT ANY ISSUES AND THE PROCEDURE WAS COMPLETED BY PERFORMING AN ANGIOPLASTY USING A PTA BALLOON. ALLEGEDLY, A STENT PLACEMENT WAS NOT NECESSARY ANYMORE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5856552 ↗
• MalfunctionJun 6, 2016Break; Fracture; Fracture

  IT WAS REPORTED THAT THE SHEATH OF THE ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM BROKE DURING DEPLOYMENT. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 5700829 ↗