Zenith Flex G42788Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002427881), received between Jun 13, 2018 and Jun 13, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Failure to Advance” (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.

• MalfunctionJun 13, 2018Material Frayed; Failure to Advance

  IT WAS REPORTED THAT THE ZENITH AAA ENDOVASCULAR GRAFT AAA ANCILLARY COMPONENT MAIN BODY EXTENSION WAS BEING USED TO REPAIR THE ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN NOTICED THAT THE TIP WAS SLIGHTLY FRAYED, BUT THEY DID NOT THINK IT WOULD AFFECT INSERTION INTO THE VESSEL. HOWEVER, THE DEVICE WOULD NOT ADVANCE INTO THE COMMON ILIAC ARTERY. A BACKUP DEVICE WAS USED TO COMPLETE THE PROCEDURE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7597413 ↗