Zenith Renu G55363Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002553634), received between Jul 9, 2018 and Jan 31, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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.

• InjuryJan 31, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  THERE IS NO NEW EVENT INFORMATION TO REPORT.

  Patient problems: No Code Available

  MAUDE report 8294153 ↗
• MalfunctionJul 9, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED A STANDARD ENDOVASCULAR PROCEDURE WAS PERFORMED ON (B)(6) 2018, TO TREAT A MALE PATIENT WITH AN ABDOMINAL AORTIC ANEURYSM (AAA). THE DEVICES IMPLANTED WERE A ZENITH RENU AAA ANCILLARY GRAFT CONVERTER (AX1-2-24-113) AND A ZSLE-13-56-ZT. A LUNDERQUIST WIRE GUIDE WAS USED. AFTER THE ENDOGRAFTS WERE IMPLANTED AN ENDOLEAK WAS SEEN DURING THE CONTRAST ANGIOGRAPHY. THERE WERE NO DIFFICULTIES DURING THE PLACEMENT OF THE DEVICE. A COOK CODA BALLOON WAS USED DURING THE PROCEDURE IN THE PROXIMAL SEALING ZONE, ABOVE THE REGION WHERE THE SUSPECTED TEAR IS LOCATED. AN INFLATION DEVICE WAS NOT USED WITH THE CODA, JUST 50/50 WATER AND CONTRAST UNTIL THE BALLOON FORMED ALONG THE SEAL ZONE. THE PATIENT WAS ON STANDARD 5000IE HEPARIN INJECTED AT THE BEGINNING OF THE CASE. NO INTERVENTIONS HAVE BEEN PERFORMED AT THIS TIME. THE PATIENT IS REPORTEDLY IN GOOD CONDITION BUT THE AAA IS STILL PERFUSED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. BECAUSE THERE IS AN ENDOLEAK AND THE ABDOMINAL ANEURYSM IS STILL PERFUSED THERE HAS TO BE AN ADDITIONAL TREATMENT. AT THIS TIME, IT IS NOT CLEAR WHICH TREATMENT THE PATIENT WILL RECEIV

  Patient problems: No Code Available

  MAUDE report 7670238 ↗