Fluency® Endovascular Stent Graft FEM12120Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04049519008677), received between Feb 3, 2016 and Jan 6, 2024 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Misfire” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 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 LEFT ARM AUXILIARY LESION, THE TIP OF THE DEPLOYMENT DEVICE ALLEGEDLY CAME OFF. IT WAS FURTHER REPORTED THAT THE DETACHED TIP ALLEGEDLY REMAINED IN THE PATIENT'S LUNG. THE CURRENT STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 18461156 ↗
• MalfunctionMay 15, 2023Misfire; Malposition of Device; Activation Failure; Misfire; Malposition of Device; Activation Failure

  IT WAS REPORTED THAT DURING STENT PLACEMENT PROCEDURE IN THE RIGHT FOREARM ARTERIOVENOUS FISTULA, THE STENT WAS ALLEGEDLY FAILED TO OPEN COMPLETELY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16930593 ↗
• MalfunctionMay 5, 2023Difficult to Remove; Misfire; Difficult to Remove; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN CEPHALIC VEIN, THE DEVICE ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS REMOVED FORCIBLY WITH GREAT DIFFICULTY. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16874875 ↗
• MalfunctionSep 29, 2022Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY PARTIAL DEPLOYED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15507502 ↗
• MalfunctionApr 14, 2020Positioning Failure; Fracture; Positioning Failure; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM1212 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A FRACTURE AND DEPLOYMENT ISSUES. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS EVENT INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE PATIENT IS A (B)(6) YEAR OLD MALE WEIGHING (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957783 ↗
• MalfunctionJan 14, 2020Positioning Failure; Fracture; Positioning Failure; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12120 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A FAILURE TO DEPLOY AND A FRACTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. THE AGE, WEIGHT, AND GENDER OF THE PATIENT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586364 ↗
• MalfunctionOct 21, 2019Difficult or Delayed Positioning; Malposition of Device; Difficult or Delayed Positioning; Malposition of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODELFEM12120 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED DIFFICULT TO DEPLOY AND MALPOSITION OF THE DEVICE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED AND THERE WAS NO REPORTED PATIENT INJURY. PATIENT AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9216549 ↗
• MalfunctionJul 16, 2019Break; Detachment of Device or Device Component; Material Deformation; Break; Detachment of Device or Device Component; Material Deformation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12120 ENDOVASCULAR STENT GRAFT ALLEGEDLY BROKE AND DETACHED. THE TIP OF THE INNER CATHETER AND GUIDEWIRE WERE REMOVED WITH A SNARE. THERE WAS NO REPORTED PATIENT INJURY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE PATIENT WAS A (B)(6) YEAR-OLD FEMALE WEIGHING (B)(6) POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8795412 ↗
• MalfunctionOct 10, 2018Misfire; Material Deformation; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR TREATMENT IN THE BASILIC VEIN, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT EXCESSIVE FORCE WAS USED TO DEPLOY THE STENT GRAFT. THE STENT GRAFT DELIVERY SYSTEM WAS REMOVED WITHOUT DIFFICULTY. 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 7953587 ↗
• MalfunctionSep 21, 2018Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY WOULD NOT DEPLOY IN THE LEFT UPPER ARM VIA A MID/UPPER ARM ACCESS SITE. REPORTEDLY, MULTIPLE ATTEMPTS WERE MADE TO DEPLOY THE STENT GRAFT, BUT WERE UNSUCCESSFUL. THE DELIVERY SYSTEM WAS REMOVED AND EXCHANGED OVER THE GUIDEWIRE FOR ANOTHER (SAME SIZE AND LENGTH) WITHOUT INCIDENT AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7900168 ↗
• MalfunctionJan 8, 2018Bent; Positioning Failure; Misfire; Bent; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING THE STENT GRAFT PLACEMENT PROCEDURE INTENDED FOR THE VENOUS PORTION OF THE AV FISTULA, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY AFTER EXCESSIVE FORCE WAS USED DUE TO THE OUTER CATHETER UNABLE TO UNSHEATHE. REPORTEDLY, THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. FURTHERMORE, POST PROCEDURE, AN ATTEMPT TO DEPLOY THE STENT GRAFT OUTSIDE WAS MADE AND THE ALLEGEDLY THE SHAFT OF THE CATHETER WAS BENDING. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7173439 ↗
• MalfunctionFeb 3, 2016Positioning Failure

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED ANY FURTHER AFTER BEING PARTIALLY RELEASED DURING A STENTING PROCEDURE FOR TREATMENT OF AN UPPER ARM FISTULA. THE ENTIRE SYSTEM COULD BE REMOVED WITHOUT ISSUE. ANOTHER STENT GRAFT OF SMALLER SIZE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5407123 ↗