Zenith Flex G48403Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10827002484037), received between Apr 10, 2015 and Apr 12, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 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.

• MalfunctionApr 12, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED A TYPE 1A ENDOLEAK OCCURRED ON A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY. DURING THE PROCEDURE, THE BALLOONING WAS PERFORMED AT THE FIRST SEALING STENT. THE ENDOLEAK WAS OBSERVED ON THE FINAL ANGIOGRAM UPON COMPLETION OF THE PROCEDURE. NO ADDITIONAL TREATMENT WAS PERFORMED. THE PHYSICIAN INTENDS TO PERFORM A COMPUTED TOPOGRAPHY ANGIOGRAM IN 30 DAYS TO DETERMINE IF ADDITIONAL PROCEDURES WILL BE REQUIRED. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14091434 ↗
• InjuryMar 30, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM (AAA) USING A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY, A TYPE 3 ENDOLEAK WAS FOUND ON THE IPSILATERAL LIMB OF THE ZENITH FLEX-ZT MAIN BODY AFTER BOTH TFLES WERE PLACED. THE LEAK WAS DISCOVERED TO BE RIGHT ABOVE THE OVERLAPPING OF THE TFLE AND THE IPSILATERAL LIMB. ANOTHER TFLE WAS PLACED TO COVER THE LEAK AND THE TYPE 3 ENDOLEAK WAS CONSIDERED RESOLVED. IT WAS REPORTED THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 6446555 ↗
• InjuryApr 10, 2015Dissection; Leak/Splash

  AN (B)(6) FEMALE PATIENT UNDERWENT AAA REPAIR BY RIGHT FEMORAL APPROACH. THE PATIENT WAS SUITABLE FOR ENDOVASCULAR REPAIR; SACCULAR ANEURYSM OF THE ABDOMINAL AORTA, NO TORTUOSITY, ENOUGH LENGTH OF PROXIMAL AND DISTAL NECK. BOTH CIA IS SHORT, HOWEVER IT WAS SECURED 30 MM FOR BOTH SIDE. AFTER PLACING THE MAINBODY GRAFT AND ILIAC LEGS, A PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED BY ANGIOGRAPHY. AFTER PLACING THE MAINBODY GRAFT AND ILIAC LEGS, A PROXIMAL TYPE I ENDOLEAK WAS CONFIRMED BY ANGIOGRAPHY. THE PHYSICIAN PLANNED TO ADD THE EXTENSION IN THE PROXIMAL NECK OF THE MAIN BODY, AND WHEN HE ATTEMPTED TO ADVANCE THE EXTENSION FROM RIGHT, HE FELT RESISTANCE. THEREFORE, HE REMOVED THE DEVICE FROM THE BODY OF THE PATIENT AND OBSERVED THE ENDOSPORIUM BETWEEN THE DILATOR TIP AND SHEATH. THE PHYSICIAN DETERMINED NOT TO ATTEMPT THE DEVICE FROM RIGHT SIDE BECAUSE OF THE RISK, AND ADVANCE THE DEVICE FROM LEFT THIS TIME, HOWEVER HE FELT RESISTANCE AGAIN. HE CONSIDERED TO REMOVE THE DEVICE BUT COULD NOT, SO HE ADVANCED THE DEVICE AS MUCH AS POSSIBLE, AND PLACED THE EXTENSION INSIDE OF THE MAIN BODY WHERE IT WAS NOT THE DESIRED POSITION. AFTERWARDS, HE ATTEMPTED TO USE STRONG FORCE TO ADVANCE THE EXT

  Patient problems: Vascular Dissection

  MAUDE report 4690253 ↗