Zenith Renu G55369Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002553696), received between Nov 21, 2019 and Nov 3, 2020 — classified as 1 injury, 1 malfunction.

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

• InjuryNov 3, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THERE WAS "DIFFICULTY WITH FLOW" DURING A PROCEDURE INVOLVING THE USE OF A ZENITH RENU AAA ANCILLARY GRAFT CONVERTER. A (B)(6) MALE PATIENT WAS UNDERGOING AN IMPLANTATION OF AN ABDOMINAL AORTIC AND ILIAC BRANCH ENDOPROSTHESIS ON (B)(6) 2020. A COOK ZENITH RENU AX1-2-26-113 CONVERTER WAS TO BE IMPLANTED FROM A 22MM DIAMETER INFRARENAL AORTA ARTERY. THE DEVICE WAS PREPARED ACCORDING TO THE INSTRUCTIONS OUTLINED IN THE IFU AND ASCENDED THROUGH THE RIGHT ILIAC ARTERY. THE DEVICE WAS POSITIONED UNDER THE LEFT RENAL ARTERY, LEAVING THE FABRIC "START MARKS" 2MM FROM THE RENAL ARTERY. THE GRAFT WAS DEPLOYED, THE GREY STABILIZER WAS "FIXED", AND THE FLEXOR SHEATH WAS RETRACTED, AT WHICH POINT THE DISTAL STENTS OF THE GRAFTS WERE DEPLOYED. THE SAFETY WIRES OF THE GUIDES WERE RELEASED, THEN THE DISTAL TRIGGER OF THE GUIDES WAS RELEASED. THE PIN VISE WAS LOOSENED AGAIN "TO RELEASE FREE FLOW" WHICH WAS NOT SUCCESSFULLY. MULTIPLE ATTEMPTS WERE MADE TO "RELEASE THE FREE FLOW, LEAVING IT FIXED TO THE CAPSULE". THE PROCEDURE WAS CONVERTED TO AN OPEN SURGERY TO RETRIEVE THE DEVICE AND PERFORM AN AORTIC REPAIR. THE PATIENT HAS REQUIRED MORE MEDICAL SUPPORT, INCURRING AN OPEN AORT

  Patient problems: No Code Available; Renal Failure

  MAUDE report 10780264 ↗
• MalfunctionNov 21, 2019Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9357542 ↗