Zenith Renu G36144Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002361444), received between Nov 17, 2017 and Nov 17, 2017 — classified as 1 death.

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.

• DeathNov 17, 2017Difficult or Delayed Positioning; Difficult or Delayed Positioning

  THE AREA REPRESENTATIVE REPORTED A (B)(6) MALE PATIENT UNDERWENT AN ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR (EVAR) PROCEDURE ON (B)(6) 2007. DURING THE EVAR PROCEDURE A ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY (CATALOG NUMBER: TFFB-32-82) WAS IMPLANTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT WAS IN A REGULAR ANNUAL FOLLOW-UP. IN THE LAST FOLLOW-UP, A TYPE IA ENDOLEAK WAS NOTICED FROM THE TFFB-32-82 WHICH IS REPORTED USING MW:1820334-2017-03782. THE PHYSICIAN ORDERED AN ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION (CATALOG NUMBER: RX1-32-62) FROM COOK TO RESOLVE THE PROBLEM. ON (B)(6) 2017, THE (B)(6) MALE PATIENT UNDERWENT A SECONDARY PROCEDURE TO REPAIR THE PROXIMAL TYPE IA ENDOLEAK. THE PHYSICIAN USED A ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION. THE PATIENT'S VESSELS WERE NOT CALCIFIED BUT WERE TORTUOUS SO THE PHYSICIAN USED ANOTHER MANUFACTURER'S WIRE GUIDE INSTEAD OF A LUNDERQUIST WIRE. [AS THE BACK UP MEYER WIRES ARE A LITTLE MORE RIGID AND PROVIDE MORE SUPPORT IN TORTUOUS VESSELS]. DURING THE SECONDARY PROCEDURE, THE PHYSICIAN EXPERIENCED DIFFICULTY DEPLOYING THE RX1-32-62. THE PHYSICIAN PUT THE DEVICE RIGHT IN PLACE, WI

  Patient problems: Blood Loss; Death; No Code Available

  MAUDE report 7040382 ↗