Zenith Flex G48409Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002484099), received between Apr 19, 2016 and Jan 13, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 13, 2017Leak/Splash; Leak/Splash

  ON (B)(6) 2016, AN (B)(6) MALE PATIENT UNDERWENT AAA REPAIR. THE PATIENT'S ANATOMY WAS SUITABLE FOR ENDOVASCULAR REPAIR. THE PHYSICIAN COIL EMBOLIZED THE RIGHT INTERNAL ILIAC ARTERY FIRST AND THEN PLACED THE BIFURCATED MAIN BODY GRAFT (1820334-2017-00013) FOLLOWED BY THE LEFT (1820334-2017-00015) AND RIGHT (1820334-2017-0016) ILIAC LEG GRAFTS AS LABELED. BALLOONING WAS ALSO PERFORMED. BY ANGIOGRAPHY FROM THE NECK SIDE, ENDOLEAK FROM THE RIGHT ABOVE THE LEFT RIM JUNCTION AND FROM BOTH LEGS WAS CONFIRMED. THE PHYSICIAN SUSPECTED IT WAS A TYPE III ENDOLEAK, SO HE PERFORMED ADDITIONAL BALLOONING AT BOTH SIDES' JUNCTION, BUT THE SITUATION WAS NOT CHANGED. THE PHYSICIAN THEN SUSPECTED A TYPE IV ENDOLEAK AND PERFORMED ANGIOGRAPHY IN THE STENT GRAFTS. THE LEAK LOOKED THE SAME AS BEFORE. HE DETERMINED IT WAS EITHER A TYPE IV OR TYPE IIIB ENDOLEAK. IT WAS DECIDED TO TAKE A WAIT-AND-SEE APPROACH BECAUSE IT WOULD BE DIFFICULT TO ADD EXTENSIONS IN EITHER TYPE OF ENDOLEAK. NEUTRALIZATION OF THE ANTI-COAGULANT ACTIVITY OF HEPARIN WAS PERFORMED BY ADMINISTRATION OF PROTAMINE AS USUAL. A WEEK AFTER THE PROCEDURE, THE PHYSICIAN CONFIRMED THAT THE ENDOLEAK STILL EXISTED DURING THE FOLLOW-UP CT EXAM.

  Patient problems: No Code Available

  MAUDE report 6250766 ↗
• InjurySep 29, 2016Leak/Splash; Leak/Splash

  AN (B)(6) MALE PATIENT UNDERWENT AN AAA REPAIR IN EARLY (B)(6) 2016. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE. AFTER PLACING ALL STENT GRAFTS AS PLANNED, AN EXCESSIVE AMOUNT OF TYPE IV ENDOLEAK WAS CONFIRMED BY FINAL ANGIOGRAPHY. ANOTHER STENT GRAFT WAS IMPLANTED. NO FURTHER INFORMATION WAS PROVIDED REGARDING PATIENT OUTCOME.

  Patient problems: No Code Available

  MAUDE report 5986915 ↗
• InjuryApr 19, 2016Leak/Splash; Material Rupture; Leak/Splash; Material Rupture

  DURING AN EVAR IN THE ABDOMINAL AORTA ON A (B)(6) YEAR OLD MALE PATIENT, AFTER IMPLANTING ALL THE LIMBS IN THE FINAL RUN, THE CLINICAL SPECIALIST AND PHYSICIAN DISCOVERED A TYPE II AND TYPE III ENDOLEAK. THE PHYSICIAN PERFORMED A SELECTIVE ANGIO AND WAS ABLE TO CONFIRM THE TYPE III. THE PHYSICIAN AND CLINICAL SPECIALIST BELIEVE THAT THERE IS A TEAR IN THE FABRIC, OR COUPLE OF THE SUTURES IN THE MAIN BODY ABOVE THE FLOW DIVIDER, WERE BROKEN. THE PHYSICIAN ATTEMPTED TO FIX IT BY IMPLANTING ADDITIONAL LIMBS, BUT TO NO EFFECT. IT WAS NOT UNTIL THE PHYSICIAN DECIDED TO REALIGN IT WITH A BIFURCATED GRAFT (ANOTHER MANUFACTURER). AFTER IMPLANTING THE GRAFT, THE TYPE III ENDOLEAK STOPPED. ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING PATIENT OUTCOME.

  Patient problems: No Code Available

  MAUDE report 5586683 ↗