Fluency® Endovascular Stent Graft FEM14080Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 04049519008707), received between Aug 10, 2016 and Feb 10, 2026 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (14 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 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Break; Detachment of Device or Device Component

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A FLUENCY PLUS ENDOVASCULAR STENT GRAFT DEVICE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE STENT DEPLOYED SUCCESSFULLY, BUT WHILE REMOVING THE STENT SHAFT, THE TIP BROKE OFF AND HAD TO BE RETRIEVED USING A SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24301885 ↗
• MalfunctionDec 4, 2025Break; Difficult to Remove; Detachment of Device or Device Component; Break; Difficult to Remove; Detachment of Device or Device Component

  ON (B)(6) 2025, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING FLUENCY STENT GRAFT . AFTER DEPLOYMENT, RESISTANCE WAS ENCOUNTERED WHILE PULLING THE DELIVERY SYSTEM OUT OF THE PATIENT. THE END OF THE DELIVERY SYSTEM BROKE OFF AND REMAINED INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED USING A SNARE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23713142 ↗
• InjurySep 12, 2025Positioning Failure; Misfire; Difficult to Advance; Positioning Failure; Misfire; Difficult to Advance

  ON (B)(6) 2025, A PATIENT UNDERWENT STENT PLACEMENT PROCEDURE USING FLUENCY PLUS ENDOVASCULAR STENT GRAFT FOR AN UNKNOWN MEDICAL CONDITION. DURING DEPLOYMENT, IT WAS REPORTED THAT THE STENT FAILED TO DEPLOY. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT EXPERIENCED PAIN, SWELLING AND HEMATOMA. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN.

  Patient problems: Extravasation; Hematoma; Pain; Swelling/ Edema

  MAUDE report 23035445 ↗
• MalfunctionAug 15, 2024Material Perforation; Misfire; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE BARE METAL ENDS OF THE STENT WERE ALLEGEDLY POKED THROUGH THE PROTECTIVE SHEATH AND WOULD NOT ENTER THE INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19989698 ↗
• MalfunctionJun 10, 2024Positioning Failure; Material Perforation; Positioning Failure; Material Perforation

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE RIGHT SUBCLAVIAN VEIN, THE STENT ALLEGEDLY DID NOT DEPLOY. IT WAS FURTHER REPORTED THAT A PIECE OF WIRE FROM THE STENT WAS ALLEGEDLY FOUND TO BE STICKING OUT OF THE SIDE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19496215 ↗
• InjurySep 22, 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 IN THE SUBCLAVIAN VEIN, THE DISTAL END OF THE STENT DID NOT FULLY DEPLOY AND WAS STUCK. IT WAS FURTHER REPORTED THAT A THREE MILLIMETER BALLOON WAS USED TO INFLATE THE DISTAL TIP OF THE STENT TO FULLY RELEASE THE STENT FROM THE CATHETER AND WAS SUCCESSFUL. FURTHERMORE, AFTER POST STENT ANGIOGRAMS, THE HEALTH CARE PERSONNEL NOTICED THAT THERE MIGHT BE THE RADIOPAQUE RING POSSIBLY MAY HAVE BEEN DISLODGED AND MIGRATED TO THE PULMONARY ARTERY. REPORTEDLY, THE HEALTH CARE PERSONNEL MENTIONED THAT THE RING HAD EMBOLIZED WITHIN THE PULMONARY ARTERY. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Embolism/Embolus

  MAUDE report 17796834 ↗
• MalfunctionNov 14, 2022Self-Activation or Keying; Material Separation; Material Perforation; Misfire; Device-Device Incompatibility; Self-Activation or Keying; Material Separation; Material Perforation; Misfire; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE AXILLARY VESSEL, THE DEVICE WAS ALLEGEDLY HAD DIFFICULTY INSERTING THE SHEATH. IT WAS FURTHER REPORTED THAT A SMALL AMOUNT OF THE STENT WAS ALLEGEDLY EXPOSED WHICH WAS NOTICED UPON REMOVAL. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15787082 ↗
• MalfunctionApr 13, 2022Break; Positioning Failure; Material Perforation; Misfire; Break; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE SUBCLAVIAN VEIN, 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 14101365 ↗
• MalfunctionApr 14, 2020Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM14080 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MATERIAL DEFORMATION AND POSITIONING PROBLEM. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO CONSEQUENCES. THE WEIGHT OF (B)(6) YEAR OLD MALE IS (B)(6) POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957789 ↗
• MalfunctionApr 14, 2020Positioning Failure; Misfire; Positioning Failure; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF REPORTED INFORMATION INDICATES THAT MODEL FEM14080, ENDOVASCULAR STENT GRAFT, ALLEGEDLY EXPERIENCED MISFIRE AND FAILURE TO DEPLOY. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT'S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957286 ↗
• MalfunctionJan 14, 2020Positioning Failure; Misfire; Positioning Failure; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM14080 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY AND MISFIRE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE; WEIGHT NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9587438 ↗
• MalfunctionJan 14, 2020Difficult or Delayed Positioning; Entrapment of Device; Malposition of Device; Difficult or Delayed Positioning; Entrapment of Device; Malposition of Device

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM14080 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A DIFFICULTY TO DEPLOY AND MALPOSITION OF DEVICE. THIS INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO REPORTED CONSEQUENCE. THE PATIENT WAS REPORTED AS A (B)(6)-YEAR-OLD FEMALE WHOSE WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9586366 ↗
• MalfunctionMar 21, 2019Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT THE ENDOVASCULAR 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 8442119 ↗
• MalfunctionFeb 27, 2019Positioning Failure; Material Invagination; Material Perforation; Positioning Failure; Material Invagination; Material Perforation

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN A BRACHIOCEPHALIC FISTULA VIA CENTRAL VENOUS ACCESS, THE DELIVERY SYSTEM WAS ALLEGEDLY DIFFICULT TO ADVANCE THROUGH THE SKIN VIA BAREBACK APPROACH WHEN THE SILICONE TIP BECAME INVAGINATED. IT WAS FURTHER REPORTED THAT UPON DEPLOYMENT ATTEMPT, THE INVAGINATED TIP BECAME CAUGHT ON THE PROXIMAL MARKERS AND FAILED TO DEPLOY. THEREFORE ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8373935 ↗
• MalfunctionNov 20, 2018Misfire; Misfire

  IT WAS REPORTED THAT DURING A VASCULAR STENT DEPLOYMENT PROCEDURE IN THE SUBCLAVIAN ARTERY VIA UPPER ARM GRAFT APPROACH, THE STENT ALLEGEDLY DEPLOYED PARTIALLY. THE DELIVERY SYSTEM WAS ABLE TO BE REMOVED THROUGH THE INTRODUCER SHEATH WITHOUT ISSUES FROM THE PATIENT. REPORTEDLY, AN ALTERNATIVE BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8090080 ↗
• MalfunctionSep 27, 2018Misfire; Malposition of Device; Device-Device Incompatibility; Misfire; Malposition of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE, THE STENT GRAFT ALLEGEDLY PARTIALLY DEPLOYED. AS A RESULT THE ACCURACY OF PLACEMENT ALLEGEDLY WAS NOT IDEAL. REPORTEDLY, ANOTHER STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7915616 ↗
• MalfunctionAug 24, 2018Positioning Failure; Material Perforation; Failure to Advance; Positioning Failure; Material Perforation; Failure to Advance

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT PROCEDURE IN THE CEPHALIC VEIN, THE STENT GRAFT ALLEGEDLY FAILED TO DEPLOY. REPORTEDLY, THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY AND WAS OBSERVED THAT ONE OF THE STENT STRUTS ALLEGEDLY PERFORATED. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7814110 ↗
• MalfunctionMay 15, 2018Positioning Failure; Fracture; Material Perforation; Positioning Failure; Fracture; Material Perforation

  IT WAS REPORTED THAT DURING A STENT GRAFT DEPLOYMENT OF THE SUBCLAVIAN VEIN, THE STENT GRAFT WAS ALLEGEDLY UNABLE TO DEPLOY. THE CATHETER WAS REMOVED WITHOUT ISSUE AND PROCEDURE WAS COMPLETED WITH ANOTHER STENT GRAFT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7516717 ↗
• MalfunctionMay 8, 2018Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT THE VASCULAR STENT GRAFT WAS ALLEGEDLY UNABLE TO DEPLOY DURING TREATMENT IN THE 90 PERCENT CALCIFIED RIGHT ILIAC ARTERY VIA THE RIGHT GROIN SFA IPSILATERAL APPROACH. THEREFORE, THE CATHETER WAS REPORTEDLY REMOVED WITHOUT INCIDENT. REPORTEDLY, AN ALTERNATIVE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7497145 ↗
• MalfunctionNov 15, 2017Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT THE ENDOVASCULAR STENT GRAFT ALLEGEDLY WOULD NOT DEPLOY FROM THE DELIVERY SYSTEM; THEREFORE, THE DEVICE WAS REMOVED WITHOUT INCIDENT. REPORTEDLY, ANGIOPLASTY WAS PERFORMED INSTEAD TO TREAT THE STENOSIS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7034724 ↗
• MalfunctionJun 20, 2017Positioning Failure; Material Perforation; Positioning Failure; Material Perforation

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE FOR TREATMENT OF A PRE-DILATED CENTRAL STENOSIS IN A LEFT UPPER ARM A/V GRAFT VIA ACCESS THROUGH THE BRACHIOCEPHALIC VEIN, THE ENDOVASCULAR STENT GRAFT COULD NOT BE DEPLOYED. UPON REMOVAL OF THE DELIVERY SYSTEM, TWO METAL STENT STRUTS WERE OBSERVED EXITING OUT OF THE SIDE OF THE DELIVERY SYSTEM SHEATH. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6653174 ↗
• MalfunctionApr 5, 2017Positioning Failure; Fracture; Positioning Failure; Fracture

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT IN THE CEPHALIC VEIN, THE OUTER CATHETER OF THE DELIVERY SYSTEMBROKE. THE DELIVERY SYSTEM WAS REMOVED WITHOUT ISSUE AND ANOTHER 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 6460716 ↗
• MalfunctionNov 14, 2016Positioning Failure; Fracture; Material Perforation; Positioning Failure; Fracture; Material Perforation

  IT WAS REPORTED THAT DURING A STENTING PROCEDURE, THE ENDOVASCULAR STENT GRAFT COULD NOT BE RELEASED BY USING THE PIN AND PULL TECHNIQUE. THEN THE BLUE OUTER CATHETER SNAPPED. 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 6099110 ↗
• MalfunctionAug 10, 2016Fracture; Activation, Positioning or Separation Problem; Fracture; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING DEPLOYMENT OF THE ENDOVASCULAR STENT GRAFT, THE OUTER CATHETER FRACTURED; HOWEVER, THE STENT GRAFT COULD BE DEPLOYED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 5865197 ↗