Fluency® Endovascular Stent Graft FEM12080Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 04049519008653), received between Dec 29, 2016 and Aug 7, 2025 — classified as 1 injury, 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 7, 2025Positioning Failure; Material Deformation; Positioning Failure; Material Deformation

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT GRAFT PLACEMENT PROCEDURE TARGETING A LEFT BRACHIAL BASILIC FISTULA USING THE FLUENCY PLUS ENDOVASCULAR STENT GRAFT. DURING THE PROCEDURE, THE STENT FAILED TO DEPLOY AS INTENDED. THE STENT DID NOT RELEASE PROPERLY AND APPEARED TO BE KINKED WITHIN THE CATHETER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22735395 ↗
• MalfunctionDec 12, 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 RIGHT SUBCLAVIAN VEIN, THE PIECE OF THE DELIVERY SYSTEM WAS ALLEGEDLY DETACHED FROM THE REST OF THE SYSTEM AFTER THE STENT WAS DEPLOYED. IT WAS FURTHER REPORTED THAT THE BROKEN PIECE OF THE DELIVERY SYSTEM WAS RETRIEVED VIA VASCULAR SNARE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20910753 ↗
• InjurySep 25, 2023Break; Misfire; Detachment of Device or Device Component; Break; Misfire; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE TO TREAT A FISTULOGRAM, RESISTANCE WAS MET DURING THE STENT GRAFT DEPLOYING ATTEMPT. IT WAS FURTHER REPORTED THAT THE PROXIMAL END OF THE STENT GRAFT ALLEGEDLY DELAYED IN OPENING DUE TO THIS INITIAL RESISTANCE AND WHEN IT OPENED THE PROXIMAL TIP OF THE CATHETER ALLEGEDLY POPPED OFF AND FLOATED INTO THE PATIENT¿S LUNGS. REPORTEDLY, MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO SNARE THE TIP. PATIENT¿S STATUS IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 17806437 ↗
• MalfunctionMay 24, 2023Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE IN THE CEPHALIC VEIN VIA LEFT SIDE FISTULA, THE STENT 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 16990431 ↗
• MalfunctionMay 9, 2023Break; Positioning Failure; Fracture; Misfire; Break; Positioning Failure; Fracture; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR THROMBUS IN DIALYSIS ACCESS, THE METAL ALLEGEDLY BROKE DURING DEPLOYMENT. IT WAS FURTHER REPORTED THAT 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 16894008 ↗
• MalfunctionApr 4, 2023Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT AXILLARY VEIN FOR STENOSIS, THE STENT 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 16675041 ↗
• MalfunctionAug 9, 2022Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE STENT 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 15190271 ↗
• MalfunctionAug 25, 2021Misfire; Misfire

  IT WAS REPORTED THAT DURING AN ANGIOPLASTY 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 12363949 ↗
• MalfunctionJul 16, 2020Misfire; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL FEM12080 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MISFIRE. THE INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO REPORTED PATIENT INJURY. PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283443 ↗
• MalfunctionApr 14, 2020Material Perforation; Misfire; Material Perforation; Misfire

  THIS REPORTED SUMMARIZES TWO MALFUNCTIONS. THE MALFUNCTIONS WERE REVIEWED AND INDICATED THAT MODEL FEM12060 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MISFIRE AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM VARIOUS SOURCES. THE MALFUNCTIONS INVOLVED BOTH PATIENTS WITH NO KNOWN IMPACT TO THE PATIENTS. ONE PATIENT WAS (B)(6) YEAR OLD MALE WEIGHING (B)(6) KGS. THE SECOND PATIENT WAS (B)(6) YEAR OLD MALE WEIGHING (B)(6) LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957287 ↗
• MalfunctionJan 14, 2020Positioning Failure; Difficult to Remove; Misfire; Positioning Failure; Difficult to Remove; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATES THAT FEM12080, ENDOVASCULAR STENT GRAFT, ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, REMOVAL DIFFICULTY, AND MISFIRE. THIS INFORMATION WAS RECIEVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A MALE PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586367 ↗
• MalfunctionSep 7, 2018Break; Positioning Failure; Fracture; Break; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING AN ENDOVASCULAR STENT GRAFT PLACEMENT PROCEDURE FOR TREATMENT OF A VENOUS LIMB SURGICAL GRAFT THROUGH A TIGHT AV GRAFT USING AN 8FR INTRODUCER SHEATH AND A 7FR INTRODUCER SHEATH WHICH WAS REMOVED PRIOR TO INSERTING THE ENDOVASCULAR STENT GRAFT DELIVERY SYSTEM, THE DEVICE ALLEGEDLY FAILED TO DEPLOY. IT WAS ALSO ALLEGED THAT THE HEALTH CARE PROVIDER APPLIED EXCESSIVE FORCE IN AN EFFORT TO DEPLOY THE STENT GRAFT THAT THE HANDLE ALLEGEDLY BROKE, AND THE OUTER CATHETER FRACTURED. REPORTEDLY, THE PROCEDURE WAS ABORTED SINCE THERE WAS NO DEVICE OF THE SAME SIZE HANDY TO CONTINUE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. DURING EVALUATION OF THE RETURNED SAMPLE A FRACTURE COULD NOT BE FOUND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7858082 ↗
• MalfunctionJun 11, 2018Bent; Entrapment of Device; Material Perforation; Material Twisted/Bent; Bent; Entrapment of Device; Material Perforation; Material Twisted/Bent

  IT WAS REPORTED THAT DURING DEPLOYMENT OF A VASCULAR STENT GRAFT VIA AN UPPER LEFT ARM ACCESS INTO A BRACHIAL CEPHALIC FISTULA WITHOUT AN INTRODUCER SHEATH, THE STENT GRAFT ALLEGEDLY GOT CAUGHT ON AN EXISTING STENT AND ONE OF THE STRUTS WAS BENT BACKWARDS. THE STENT GRAFT WAS REMOVED WITHOUT INCIDENT. REPORTEDLY, ANOTHER STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7589854 ↗
• MalfunctionMar 30, 2018Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED DURING AN A/V FISTULA GRAFT THROMBECTOMY VENOUS ANASTOMOSIS TREATMENT. THEREFORE, THE DEVICE WAS EXCHANGED FOR ANOTHER AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7387122 ↗
• MalfunctionDec 29, 2016Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING TREATMENT OF A STENOSIS IN A CEPHALIC-AXILLARY ANASTOMOSIS VIA BRACHIOCEPHALIC AVF THE STENT GRAFT FAILED TO DEPLOY AND THE OUTER CATHETER FRACTURED. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00335.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6212699 ↗
• MalfunctionDec 29, 2016Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING TREATMENT OF A STENOSIS IN A CEPHALIC-AXILLARY ANASTOMOSIS VIA BRACHIOCEPHALIC AVF THE STENT GRAFT FAILED TO DEPLOY AND THE OUTER CATHETER FRACTURED. THE DEVICE WAS REMOVED AND ANOTHER DEVICE OF THE SAME SIZE AND BRAND WAS USED, BUT FAILED IN THE SAME WAY. THEN ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THIS IS THE SAME PATIENT AS REPORTED IN MEDWATCH REPORT # 9681442-2016-00336.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6212625 ↗