Fluency® Endovascular Stent Graft FEM07060Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 04049519008448), received between Oct 8, 2015 and Feb 13, 2026 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Misfire” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Break; Misfire

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING FLUENCY FOR POPLITEAL ANEURYSM IN PATIENT WITH HEPARIN ALLERGY VIA CONTRALATERAL FEMORAL ARTERY. REPORTEDLY, THE STENT MALFUNCTIONED AND ALLEGEDLY BROKEN. THE DEVICE WAS PARTIALLY DEPLOYED AND EVENTUALLY REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24330033 ↗
• MalfunctionNov 10, 2023Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT ALLEGEDLY PARTIALLY DEPLOYED AND COULD NOT BE OPENED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18110204 ↗
• MalfunctionOct 31, 2023Positioning 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 ALLEGEDLY FAILED TO DEPLOY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18036910 ↗
• MalfunctionAug 1, 2023Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY TRIED TO DEPLOY AND IT WOULD NOT RETRACT OUTER CATHETER. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17434373 ↗
• MalfunctionDec 28, 2022Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE DEVICE 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 16058764 ↗
• MalfunctionNov 24, 2022Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY FOUND TO BE DETACHED ON THE SHAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15859706 ↗
• MalfunctionMar 2, 2022Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT IN THE UPPER ARM, THE DISTAL PORTION OF THE STENT DEPLOYED; HOWEVER, THE OUTER CATHETER WOULD NOT RETRACT. THE PHYSICIAN FELT MUCH RESISTANCE AND ABORTED THE DEPLOYMENT. THE DEVICE WAS REMOVED FROM THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13652549 ↗
• MalfunctionNov 3, 2020Positioning Failure; Misfire; Positioning Failure; Misfire

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10777114 ↗
• MalfunctionOct 22, 2020Positioning Failure; Fracture; Misfire; Positioning Failure; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM07060 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE, FRACTURE AND MISFIRE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE ONE REPORTED MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE FEMALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10722815 ↗
• MalfunctionJul 20, 2020Break; Positioning Failure; Fracture; Difficult to Remove; Break; Positioning Failure; Fracture; Difficult to Remove

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM07060 ENDOVASCULAR STENT GRAFT ALLEGEDLY BROKE AND EXPERIENCED POSITION FAILURE. 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 10299554 ↗
• MalfunctionJan 9, 2020Positioning Failure; Fracture; Positioning Failure; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED MALFUNCTION INDICATED THAT MODEL FEM07060 ALLEGEDLY EXPERIENCED A FRACTURE AND FAILURE TO DEPLOY. THIS REPORT WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE 27 YEAR OLD FEMALE PATIENT'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9570395 ↗
• MalfunctionJan 8, 2019Premature Activation; Positioning Problem; Premature Activation; Positioning Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN A U-SHAPED A/V GRAFT IN THE LET UPPER ARM, THE STENT GRAFT ALLEGEDLY HAD DIFFICULTY REACHING THE LESION VIA A BAREBACK APPROACH. IT WAS FURTHER REPORTED THAT IT WAS REMOVED AND FLUSHED. FURTHERMORE, AS IT WAS BEING ADVANCED TO THE LESION THE END OF THE STENT GRAFT ALLEGEDLY PREMATURELY DEPLOYED. THE DEVICE WAS SUCCESSFULLY REMOVED 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 8229423 ↗
• MalfunctionJun 4, 2018Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN A LEFT LOWER ARM LOOP GRAFT, THE PROXIMAL END OF THE OUTER SHEATH THAT MEETS THE DISTAL END OF THE TUOHY-BORST VALVE ALLEGEDLY POPPED OUT AND SUBSEQUENTLY LED TO THE STENT PARTIALLY DEPLOYING. IT WAS FURTHER REPORTED THAT THE STENT AND DELIVERY SYSTEM WAS REMOVED SUCCESSFULLY AND ANOTHER STENT WAS DEPLOYED AT THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7567567 ↗
• MalfunctionJun 4, 2018Fracture; Misfire; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN A LEFT LOWER ARM LOOP GRAFT, THE PROXIMAL END OF THE OUTER SHEATH THAT MEETS THE DISTAL END OF THE TUOHY-BORST VALVE ALLEGEDLY POPPED OUT AND SUBSEQUENTLY LED TO THE STENT PARTIALLY DEPLOYING. IT WAS FURTHER REPORTED THAT THE STENT AND DELIVERY SYSTEM WAS REMOVED SUCCESSFULLY AND ANOTHER STENT WAS DEPLOYED AT THE TARGET LESION. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7567566 ↗
• MalfunctionOct 8, 2015Break; Difficult to Insert; Device Damaged Prior to Use; Split

  IT WAS REPORTED THAT WHILE PERFORMING A SHEATHLESS STENT GRAFT PLACEMENT IN THE LEFT AXILLARY VEIN AT A VENOUS ANASTAMOSIS WITH ACCESS THROUGH THE LEFT ARM, THE DELIVERY SYSTEM COULD NOT BE INSERTED INTO THE PATIENT AT THE ACCESS SITE SINCE THE TIP FELT SOFT AND EVEN SPLIT A LITTLE. THE DEVICE WAS NOT USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER STENT GRAFT. THERE WAS NO REPORTED PATIENT INJURY.

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

  MAUDE report 5136586 ↗