Zenith Renu G36137Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002361376), received between Oct 19, 2018 and Oct 19, 2018 — classified as 1 death.

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

• DeathOct 19, 2018Difficult or Delayed Separation; Difficult or Delayed Separation

  ADDITIONAL INFORMATION PROVIDED BY FACILITY 09NOV2018. IN (B)(6) 2011, A GORE C3 DEVICE HAD BEEN INSERTED (23MM MAIN BODY): 23MM X18CM X 14.5MM (INSERTED FROM THE RIGHT). 14.5MM LEFT LIMB. DUE TO A CONCERN ABOUT GROWING SAC SIZE (WITH DILATING NECK) AND CORRESPONDING DECREASED AREA OF SEAL, IT WAS DECIDED TO INSERT AN AORTIC CUFF. THE PATIENT WAS UNDER GENERAL ANAESTHETIC AND A RIGHT GROIN CUTDOWN HAD BEEN PERFORMED. A 6F SHEATH HAD BEEN INSERTED INTO THE LEFT FEMORAL ARTERY, THROUGH WHICH PIGTAIL RUNS WERE PERFORMED. JUST PRIOR, DURING AND IMMEDIATELY AFTER THE MALFUNCTION, THE PATIENT HAD REMAINED HEMODYNAMICALLY STABLE. THE DEVICE WAS INSERTED AND ANGIOGRAPHY PERFORMED. A BLACK INK MARKER WAS USED TO DELINEATE THE LEVEL OF THE LOWEST RENAL ARTERY BY DRAWING ITS LOCATION ON THE SCREEN. ENSURING THE MARKERS WERE CORRECT, THE RX1 GRAFT WAS DEPLOYED BY WITHDRAWING THE SHEATH. POSITION AT THIS POINT WAS SATISFACTORY. THE BLACK (PROXIMAL) TRIGGER WIRE RELEASE MECHANISM WAS REMOVED COMPLETELY. THE PIN VISE WAS SUBSEQUENTLY LOOSENED. AN ATTEMPT WAS MADE TO DEPLOY THE SUPRARENAL STENT BY ADVANCING THE TOP CAP INNER CANNULA. THE STENT DID NOT DEPLOY. AT THIS POINT, WE STOPPED AND CONSULTE

  Patient problems: Death

  MAUDE report 7986116 ↗