Zenith Flex G42785Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002427850), received between Mar 17, 2017 and Feb 26, 2021 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathFeb 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A STUDY PATIENT DEVELOPED A TYPE 1B ENDOLEAK FOLLOWING IMPLANTATION OF A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION. ON (B)(6) 2017, A CT SCAN PERFORMED SHOWED A STABLE, TYPE IV THORACOABDOMINAL ANEURYSM WITH MILD ILIAC ANGULATION. THE PATIENT'S CELIAC, SUPERIOR-MESENTERIC (SMA), AND RIGHT RENAL ARTERIES WERE PATENT. THE LEFT RENAL ARTERY WAS NOTED TO BE OCCLUDED. NO RENAL INFARCTS WERE VIEWED. PATIENT MEASUREMENTS WERE RECORDED TO BE: MAXIMUM ANEURYSM DIAMETER: 59 MM LENGTH FROM CELIAC TO SMA: 15 MM LENGTH FROM CELIAC TO RIGHT RENAL: 40 MM LENGTH FROM CELIAC TO LEFT RENAL: 0 MM LENGTH FROM SMA TO RIGHT RENAL: 25 MM LENGTH FROM THE LOWEST RENAL ARTERY TO START OF THE ANEURYSM (MEASURED FROM DISTAL-MOST ASPECT OF RENAL ARTERY): 0 MM. ON (B)(6) 2018, THREE COOK CUSTOM-MADE DEVICES, THE COMPLAINT DEVICE, AND ONE COMPETITOR DEVICE WERE IMPLANTED WITHOUT DIFFICULTIES DURING AN ENDOVASCULAR PROCEDURE. POST-PROCEDURAL IMAGING REVEALED EVIDENCE OF A TYPE 1A ENDOLEAK, WHICH IS REPORTED UNDER MDR REF. #3002808486-2019-00778. NO DEVICE INTEGRITY ISSUES OR TECHNICAL ABNORMALITIES WERE NOTED. THE PATIENT WAS DISCHARGED ON (B)(6) 2018. ON (B)(6

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Death; Embolism/Embolus; Ischemia; No Code Available; Paraplegia; Unspecified Tissue Injury

  MAUDE report 11385781 ↗
• MalfunctionMar 17, 2017Material Deformation; Material Deformation

  ON (B)(6) 2017, A (B)(6) FEMALE PATIENT UNDERWENT A PROCEDURE FOR ENDOVASCULAR ANEURYSM REPAIR (EVAR). THIS PATIENT WAS NOT A ANATOMICALLY SUITABLE FOR THE PROCEDURE SINCE SEVERE CURVATURE WAS OBSERVED FROM THE PROXIMAL NECK TO THE ANEURYSM, HOWEVER, THE PHYSICIAN OPTED TO PERFORM THE EVAR DUE TO THE RISK ASSOCIATED WITH AN OPEN ABDOMINAL SURGERY EXACERBATED BY THE PATIENT'S AGE. AN ACCESS ROUTE LARGER THAN 7.7MM WAS MADE AND IT WAS NOTED THAT MILD CALCIFICATION EXISTED IN THE COMMON ILIAC ARTERY (CIA) AND THE EXTERNAL ILIAC ARTERY (EIA). THE PROCEDURE WAS PLANNED ACCORDING TO AN ANTICIPATED PROXIMAL TYPE I ENDOLEAK DUE TO SEVERE TORTUOSITY FROM THE PROXIMAL NECK TO THE ANEURYSM AND A BODY EXTENSION PLACEMENT WAS PLANNED AS ADDITIONAL TREATMENT IF NECESSARY. FIRST, EVAR WITH MAIN BODY, IPSILATERAL AND CONTRALATERAL ILIAC LEGS WITH BALLOON TOUCH WAS COMPLETED. ANGIOGRAPHY CONFIRMED A PROXIMAL TYPE I ENDOLEAK AS PREDICTED. THE PHYSICIAN PERFORMED BODY EXTENSION PLACEMENT AS PLANNED. A ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION WAS SELECTED AND INSERTED INTO THE PATIENT. HOWEVER, THE PHYSICIAN ENCOUNTERED STRONG RESISTANCE AT THE PUNCTURE SITE, SO HE REM

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6412877 ↗