Zenith Flex G48415Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10827002484150), received between Nov 4, 2014 and Apr 1, 2020 — classified as 2 deaths, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• DeathApr 1, 2020Material Disintegration; Fluid/Blood Leak; Separation Problem; Material Disintegration; Fluid/Blood Leak; Separation Problem

  IT WAS REPORTED THAT THE SUPRARENAL STENTS OF A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY SEPARATED, RESULTING IN THE PATIENT'S ANEURYSM RUPTURING. CONSEQUENTLY, THE PATIENT DIED. ON (B)(6) 2020 (APPROXIMATELY 3.5 YEARS FOLLOWING THE ORIGINAL DEVICE IMPLANTATION), THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT AS SYMPTOMATIC WITH BOTH BACK AND ABDOMINAL PAIN. CT IMAGING SHOWED SEPARATION OF THE SUPRARENAL STENTS, GRAFT DISINTEGRATION, AND AN ANEURYSM RUPTURE, SO A SECONDARY PROCEDURE IN WHICH A COMPETITOR THORACIC GRAFT WAS IMPLANTED WAS PROMPTED. BALLOONING WAS DONE IN ALL SEAL ZONES. THE ISSUE TEMPORARILY RESOLVED AFTER THE SECONDARY PROCEDURE, BUT THE PATIENT PASSED "SOME TIME AFTER" DUE TO COMPLICATIONS FROM THE ANEURYSM RUPTURE. ADDITIONAL INFORMATION REGARDING THE PATIENT, DEVICE, AND EVENT HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Abdominal Pain; Death; No Code Available

  MAUDE report 9912404 ↗
• InjuryOct 3, 2019Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 9153006 ↗
• MalfunctionJun 26, 2019Difficult to Remove; Difficult to Remove

  ADDITIONAL INFORMATION REGARDING PATIENT CONDITION WAS RECEIVED ON 13JUN2019 BUT WAS INADVERTENTLY LEFT OUT OF THE INITIAL MDR REPORT. IT WAS REPORTED THAT NO CALCIFICATION WAS PRESENT IN THE VESSELS CONTAINING THE GRAFTS. IT WAS ALSO REPORTED THAT THERE WAS "SOME SLIGHT TORTUOSITY ON THE RIGHT COMMON ILIAC ARTERY" AND "APPROXIMATELY 45 DEGREE" ANGULATION WITHIN THE ANEURYSM NECK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8736427 ↗
• DeathNov 4, 2014Leak/Splash

  ADD'L INFO PROVIDED ON 11/03/2014: THE PT EXPIRED THAT NIGHT.

  Patient problems: Rupture

  MAUDE report 4254553 ↗