Zenith Flex G48457Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002484570), received between May 10, 2018 and May 10, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 10, 2018Leak/Splash; Torn Material; Leak/Splash; Torn Material

  IT WAS REPORTED THAT DURING AN EXPLANT PROCEDURE A TYPE III ENDOLEAK OBSERVED AND TREATED. THE (B)(6) MALE PATIENT RECEIVED AN ENDOVASCULAR GRAFT ON (B)(6) 2011 FOR AN ANEURYSM MEASURING ~5 CM. A MAIN BODY AND TWO LIMBS WERE IMPLANTED. OVER TIME THE ANEURYSM SAC CONTINUED TO FILL AND THE MOST RECENT SCAN SHOWED THE SAC HAD GROWN TO APPROXIMATELY 9 CM. IT LOOKED LIKE A TYPE 2 ENDOLEAK WITH A PATENT INFERIOR MESENTERIC ARTERY OR PATENT LUMBAR ARTERIES. THE PATIENT WAS NOT SYMPTOMATIC. ON (B)(6) 2018, THE PATIENT UNDERWENT OPEN SURGERY TO EXPLANT THE ENDOGRAFT DURING WHICH, THE SURGEON NOTICED A GRAFT TEAR IN THE LEFT COMMON ILIAC. A TYPE 3 ENDOLEAK WAS CAUSING THE SAC TO FILL. THE SURGEONS CUT THE MAIN BODY GRAFT UNDER THE FIRST COVERED STENT, LEAVING THE SUPRARENAL STENT AND THE FIRST COVERED STENT OF THE ENDOGRAFT IN THE AORTA. THE SURGEON SUTURED A NEW GRAFT TO THE REMAINING FABRIC OF THE COOK ENDOGRAFT.

  Patient problems: No Code Available

  MAUDE report 7503872 ↗