Fluency® Endovascular Stent Graft FEL12120Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04049519008325), received between Apr 12, 2019 and Aug 25, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 25, 2023Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT THE STENT GRAFT DID NOT DEPLOY FROM THE DELIVERY SYSTEM DURING A STENT GRAFT PLACEMENT PROCEDURE TO TREAT A LEFT ARM ARTERIOVENOUS FISTULA (AVF) OUTFLOW VEIN RUPTURE ACCESSED THROUGH LEFT ARTERIOVENOUS FISTULA. IT WAS FURTHER REPORTED THAT THE DEVICE WAS FLUSHED, A 0.035" GUIDEWIRE AND A 10F INTRODUCER SHEATH WERE USED FOR ACCESS, THE LESION WAS PRE-DILATED, AND THERE WAS NO TORTUOSITY OR CALCIFICATION WITHIN THE VESSEL. THE DEVICE WAS REPORTEDLY REMOVED FROM THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17622328 ↗
• MalfunctionApr 21, 2023Positioning Failure; Misfire; Positioning Failure; Misfire

  IT WAS REPORTED THAT DURING A STENT PLACEMENT PROCEDURE VIA LEFT ARM BASILIC VEIN, THE STENT ALLEGEDLY DID NOT DEPLOY. FURTHER THE STENT AND DEPLOYMENT SYSTEM WAS REMOVED FROM PATIENT BODY. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16782775 ↗
• MalfunctionApr 12, 2019Difficult or Delayed Positioning; Fracture; Difficult or Delayed Positioning; Fracture

  IT WAS REPORTED THAT DURING DEPLOYMENT OF AN ENDOVASCULAR STENT GRAFT IN THE MID-CEPHALIC VEIN, THE FIRST TWO CM OF THE STENT GRAFT DEPLOYED WITHOUT ISSUE, BUT THE REMAINING LENGTH OF THE STENT GRAFT ALLEGEDLY DEPLOYED SLOWLY. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509358 ↗
• MalfunctionApr 12, 2019Difficult or Delayed Positioning; Fracture; Difficult or Delayed Positioning; Fracture

  IT WAS REPORTED THAT DURING DEPLOYMENT OF AN ENDOVASCULAR STENT GRAFT IN THE MID-CEPHALIC VEIN, THE FIRST TWO CM OF THE STENT GRAFT DEPLOYED WITHOUT ISSUE, BUT THE REMAINING LENGTH OF THE STENT GRAFT ALLEGEDLY DEPLOYED SLOWLY. THE PROCEDURE WAS COMPLETED WITHOUT INCIDENT. THERE WAS NO REPORTED PATIENT INJURY. UPON SAMPLE RETURN THE OUTER SHEATH WAS FOUND FRACTURED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8509248 ↗