Zenith Renu G36135Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002361352), received between Dec 29, 2017 and Dec 29, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• InjuryDec 29, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT THE ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION "DID NOT OPEN AS EXPECTED AND THE FINAL ANGIOGRAM SHOWED THAT THE RIGHT LOWER RENAL ARTERY WAS PARTIALLY COVERED. THE RX1 26-62 WAS INSERTED AND THE PROXIMAL GOLD MARKERS WERE PLACED CORRECTLY IN RESPECT OF THE LOWER RIGHT RENAL ARTERY, APPROXIMATELY 4 MM INFERIOR TO MOST INFERIOR RENAL ARTERY. THE DEPLOYMENT WAS COMPLETED PER THE INSTRUCTIONS FOR USE AND THERE WAS NO OFF LABEL USE OF THE DEVICE. THE FINAL ANGIOGRAM SHOWED UP WITH A PARTIAL COVERING OF THE RIGHT, LOWER RENAL ARTERY. FORTUNATELY, THE SURGEON WAS ABLE TO PRESERVE FLOW TO THE RENAL ARTERY BY INTRODUCING A STENT INTO THE RENAL ARTERY. NO ADDITIONAL ADVERSE EFFECTS TO THE PATIENT WERE REPORTED.

  Patient problems: No Code Available

  MAUDE report 7155071 ↗