Zenith Renu G55406Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002554068), received between Oct 10, 2017 and Oct 10, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (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.

• MalfunctionOct 10, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE AREA REPRESENTATIVE REPORTED ATTENDING AN AORTIC ANEURYSM REPAIR OF AN ANGULATED POSTERIOR DIVING AORTA. AS REPORTED, WHEN THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION IT WAS VERY HARD TO PUSH UP THE TOP CAP. A SIGNIFICANT AMOUNT OF FORCE WAS NEEDED IN ORDER TO RELEASE THE SUPRARENAL STENTS. IN SPITE OF THE DIFFICULTY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE EFFECTS OR CONSEQUENCES TO THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6937658 ↗