Zenith Renu G55407Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002554075), received between Jul 28, 2017 and Jul 28, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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.

• InjuryJul 28, 2017Material Fragmentation; Difficult to Remove; Material Fragmentation; Difficult to Remove

  IT WAS REPORTED THAT A ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION WAS USED DURING A RUPTURED ABDOMINAL AORTIC ANEURYSM (AAA) REPAIR PROCEDURE. WHEN AN ATTEMPT WAS MADE TO RETRIEVE THE INNER POSITIONER, IT BECAME CAUGHT ON AN INTERNAL STENT AND THE STENT HAD TO BE EXPLANTED. THE PROCEDURE WAS THEN CHANGED TO AN OPEN SURGICAL PROCEDURE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2017. THE PATIENT PRESENTED WITH A RUPTURED AAA AND WAS TREATED WITH A NORMAL 28X82 AAA FLEX GRAFT. A SMALL LEAK WAS NOTED DUE TO POSITIONING. A 28 RENU CUFF WAS THEN PLACED AND DEPLOYED WITH NO APPARENT ISSUES. THE GREY POSITIONER WAS NOTED MORE DIFFICULT TO REMOVE THAN NORMAL WHEN ATTEMPTING TO RETRIEVE THE TOP CAP. AT THAT TIME FLUOROSCOPY SHOWED A STENT IN THE BIFURCATION OF THE ORIGINAL FLEX BODY. THE PHYSICIAN ACKNOWLEDGED THAT THE RENU CUFF WAS STILL IN NORMAL POSITION. ULTIMATELY THE DEVICE WAS REMOVED VIA AN OPEN REPAIR PROCEDURE. IT WAS REPORTED THAT THE PATIENT DID WELL AND WAS SUBSEQUENTLY DISCHARGED.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6752051 ↗