Fluency® Endovascular Stent Graft FEM12060Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 04049519008646), received between Jun 30, 2017 and Apr 2, 2026 — classified as 1 death, 6 injuries, 39 malfunctions.

The most frequently reported specific device problem is “Positioning Failure” (22 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 2, 2026Failure to Advance; Misfire; Material Deformation

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING A FLUENCY STENT. DURING ADVANCEMENT OF THE STENT OVER THE GUIDEWIRE, RESISTANCE WAS ENCOUNTERED, PROMPTING REMOVAL OF THE DEVICE. UPON REMOVAL, A KINK IN THE STENT WAS IDENTIFIED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24761946 ↗
• MalfunctionMar 25, 2026Premature Activation

  ON (B)(6) 2026, A PATIENT UNDERWENT A STENT PLACEMENT PROCEDURE USING THE FLUENCY PLUS ENDOVASCULAR STENT. IT WAS REPORTED THAT DURING THE PROCEDURE, THEY ATTEMPTED TO BAR BACK THE STENT, BUT UPON ENTERING THE PATIENT, THE STENT ALLEGEDLY PREMATURELY DEPLOYED. THE PHYSICIAN WAS ABLE TO SUCCESSFULLY REMOVE THE STENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24685099 ↗
• MalfunctionNov 7, 2024Break; Migration or Expulsion of Device; Detachment of Device or Device Component; Break; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN LEFT SUBCLAVIAN ARTERY DURING A LEFT FISTULOGRAM, THE ONE TIP OF THE STENT DELIVERY CATHETER ALLEGEDLY BROKE OFF INSIDE THE VESSEL. IT WAS FURTHER REPORTED THE MULTIPLE SUPPLIES WERE OPENED TO RETRIEVE THE BROKEN TIP, AND THE PIECE WAS EVENTUALLY EXTRACTED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20629155 ↗
• MalfunctionAug 22, 2024Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, WHEN THE DEVICE REMOVED FROM THE PATIENT'S BODY, THE PART OF THE CATHETER CONTAINING STENT WAS APPARENTLY RETRACTED SLIGHTLY. IT WAS FURTHER REPORTED THAT THE DEVICE ALLEGEDLY HAD GOTTEN STUCK INSIDE WHILE ATTEMPTING TO DEPLOY THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20031746 ↗
• MalfunctionJul 23, 2024Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PROCEDURE IN THE CENTRAL VEIN, THE STENT ALLEGEDLY DID NOT DEPLOY AND IT WAS STUCK. IT WAS FURTHER REPORTED THAT THE STENT ALLEGEDLY WAS NOT DEPLOYED AT ALL. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804129 ↗
• MalfunctionJun 13, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE DEPLOYMENT SYSTEM ALLEGEDLY KINKED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19526062 ↗
• MalfunctionJun 10, 2024Device Contamination with Chemical or Other Material; Packaging Problem; Device Contamination with Chemical or Other Material; Packaging Problem

  IT WAS REPORTED THAT DURING PREPARATION OF A STENT GRAFT PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY FOUND TO BE ARRIVED WITH WATER DAMAGE. IT WAS FURTHER REPORTED THAT THERE WAS WATER DAMAGE TO THE INNER PACKAGING AND THE DEVICE WAS ALLEGEDLY FOUND TO BE DAMAGED. THERE WAS NO REPORTED PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495961 ↗
• MalfunctionMay 13, 2024Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE SUBCLAVIAN VIA THE LEFT UPPER ARM ACCESS, THE STENT ALLEGEDLY DID NOT DEPLOY OFF OF THE 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 19296836 ↗
• InjuryApr 4, 2024Break; Migration or Expulsion of Device; Detachment of Device or Device Component; Break; Migration or Expulsion of Device; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE CEPHALIC ARCH VIA LEFT UPPER ARM ARTERIOVENOUS FISTULA, A PIECE OF THE CATHETER FROM THE STENT GRAFT WAS ALLEGEDLY FOUND INSIDE THE PATIENT WHILE DEPLOYING. IT WAS FURTHER REPORTED THAT THE PIECE WAS IDENTIFIED AS MARKER ON THE CATHETER. REPORTEDLY, IT WAS ATTEMPTED TO RETRIEVE USING SNARE BUT UNSUCCESSFUL AND THE SEGMENT MIGRATED TO THE LUNG. THE PATIENT HAS NOT REPORTED ANY SYMPTOMS. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 19039430 ↗
• MalfunctionJun 30, 2023Misfire; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE IN THE LEFT ARM, THE STENT ALLEGEDLY DEPLOYED PARTIALLY. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17234976 ↗
• MalfunctionMar 28, 2023Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR STENOSIS IN THE SUBCLAVIAN VEIN, THE STENT ALLEGEDLY FAILED TO DEPLOY. IT WAS FURTHER REPORTED THAT UPON ATTEMPTING TO DEPLOY VIA PIN AND PULL METHOD, THE STENT ALLEGEDLY BUCKLED AND WOULD NOT COMPLETELY DEPLOY. REPORTEDLY THE STENT WAS WITHDRAWN AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16626353 ↗
• MalfunctionMar 6, 2023Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE FOR STENOSES AREA OF CEPHALIC VEIN, THE STENT GRAFT 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 16492819 ↗
• InjuryMar 4, 2023Break; Difficult to Advance; Break; Difficult to Advance

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE SHEATH WAS USED TO DILATE AND DEPLOY THE STENT. IT WAS FURTHER REPORTED THAT A PIECE OF DEPLOYMENT CATHETER WAS LEFT ALLEGEDLY INSIDE THE PATIENT. REPORTEDLY, THE BROKEN CATHETER SEGMENT WAS TRIED TO RETRIEVE USING A SNARE BUT IT ALLEGEDLY FLOATED DOWN INTO THE PULMONARY ARTERY AND IT CAUSED ARRHYTHMIAS THUS THE RETRIEVAL PROCEDURE HAD TO BE STOPPED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 16483364 ↗
• MalfunctionMay 31, 2022Fracture; Fracture

  IT WAS REPORTED THAT PRIOR TO A STENT GRAFT PLACEMENT PROCEDURE, THE STENT WAS ALLEGEDLY BROKEN. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14545525 ↗
• MalfunctionSep 6, 2021Fracture; Material Perforation; Misfire; Material Deformation; Fracture; Material Perforation; Misfire; Material Deformation

  IT WAS REPORTED THAT DURING STENT PLACEMENT ON SUBCLAVIAN VEIN VIA RUE AVF, STENT ALLEGEDLY PARTIALLY DEPLOYED. IT WAS FURTHER REPORTED THAT THE SHEATH WAS PERFORATED. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12427041 ↗
• InjuryAug 22, 2021Break; Material Separation; Obstruction of Flow; Break; Material Separation; Obstruction of Flow

  IT WAS REPORTED THAT DURING A STENT GRAFT PLACEMENT PROCEDURE, THE MARKER BAND ON THE OUTER SHEATH OF THE DEVICE ALLEGEDLY SEPARATED AND CREATED AN OCCLUSION WITHIN THE STENT. THE PATIENT STATUS WAS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 12352007 ↗
• MalfunctionOct 23, 2020Positioning Failure; Entrapment of Device; Material Perforation; Positioning Failure; Entrapment of Device; Material Perforation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATES THAT MODEL FEM12060 ENDOVASCULAR STENT GRAFT ALLEGEDLY ENTRAPMENT OF DEVICE, MATERIAL PERFORATION AND POSITIONING FAILURE. THE INFORMATION WAS RECEIVED FROM A SINGLE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. PATIENTS' AGE, WEIGHT AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10731504 ↗
• MalfunctionJul 14, 2020Positioning Failure; Material Perforation; Misfire; Positioning Failure; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12060 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, PARTIAL DEPLOYMENT AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED A PATIENT WITH NO CONSEQUENCES. THE PATIENT IS A (B)(6) YEAR OLD FEMALE WHO'S WEIGHT WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273367 ↗
• MalfunctionJul 14, 2020Positioning Failure; Material Perforation; Positioning Failure; Material Perforation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12060 ENDOVASCULAR STENT GRAFT ALLEGEDLY FAILURE TO DEPLOY. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION INVOLVED ONE PATIENT WITH NO PATIENT CONSEQUENCES. AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10273360 ↗
• MalfunctionApr 14, 2020Fracture; Misfire; Fracture; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12060 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED MISFIRE AND FRACTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THE MALFUNCTION INVOLVED A PATIENT WITH NO KNOWN IMPACT TO THE PATIENT. THE PATIENT¿S AGE, WEIGHT, AND GENDER WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957509 ↗
• MalfunctionApr 14, 2020Positioning Failure; Fracture; Positioning Failure; Fracture

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12060 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED POSITIONING FAILURE AND FRACTURE. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE PATIENT IS 61YEARS OLD, FEMALE AND 160LBS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9957508 ↗
• MalfunctionJan 9, 2020Positioning Failure; Material Perforation; Positioning Failure; Material Perforation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12060 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. OF THE ONE ALLEGATION OF FAILURE TO DEPLOY AND MATERIAL PERFORATION, THERE WAS AN INVOLVED PATIENT WITH NO PATIENT CONSEQUENCES. THERE WAS NO PROVIDED PATIENT INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9572241 ↗
• MalfunctionJan 9, 2020Material Perforation; Misfire; Material Perforation; Misfire

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12060 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED A MISFIRE AND MATERIAL PERFORATION. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. THIS MALFUNCTION DID INVOLVE PATIENTS WITH NO REPORTED PATIENT INJURY. THE MALE PATIENT'S AGE AND WEIGHT WERE NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9571296 ↗
• MalfunctionOct 14, 2019Positioning Failure; Retraction Problem; Material Perforation; Positioning Failure; Retraction Problem; Material Perforation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12060 ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCED FAILURE TO DEPLOY, RETRACTION PROBLEMS, MATERIAL PERFORATION, AND MISFIRING. THIS INFORMATION WAS RECEIVED FROM ONE SOURCE. ONE PATIENT WAS INVOLVED WITH NO PATIENT CONSEQUENCES. THE PATIENT WAS A (B)(6) YEAR OLD MALE WEIGHING (B)(6) POUNDS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188646 ↗
• MalfunctionOct 14, 2019Positioning Failure; Material Perforation; Positioning Failure; Material Perforation

  THIS REPORT SUMMARIZES ONE MALFUNCTION. A REVIEW OF THE REPORTED INFORMATION INDICATED THAT MODEL FEM12060. ENDOVASCULAR STENT GRAFT ALLEGEDLY EXPERIENCE FAILURE TO DEPLOY AND MATERIAL PERFORATION. THIS REPORT WAS RECEIVED FROM A SINGLE SOURCE. THIS EVENT INVOLVED A PATIENT WITH NO REPORTED PATIENT INJURY. THE PATIENT IS (B)(6) YEARS OLD, FEMALE HOWEVER, WEIGHT, WAS NOT PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188627 ↗