Zenith Renu G55382Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10827002553825), received between May 1, 2019 and Oct 10, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Activation Problem” (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 18, 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.

• InjuryOct 10, 2022Difficult to Remove; Material Separation; Migration; Difficult to Remove; Material Separation; Migration

  ADDITIONAL INFORMATION WAS RECEIVED ON 18OCT2022 ABOUT THE COOK ZENITH RENU AAA ANCILLARY GRAFT CONVERTER USED DURING A PROCEDURE FOR A PATIENT WITH THE PRE-EXISTING CONDITION OF AN ANGLED NECK. THE PHYSICIAN WAS ABLE TO ORIGINALLY LAND THE DEVICE IN THE PLANNED TARGET ZONE; HOWEVER, THE GRAFT MIGRATED AND THE FABRIC PARTIALLY COVERED THE LEFT RENAL ARTERY. IN RETURN, AN ADDITIONAL PROCEDURE WAS PERFORMED OF STENTING THE LEFT RENAL ARTERY. THE ANGULATION OF THE ANEURYSM NECK RELATIVE TO THE SUPRARENAL AORTA AS WELL AS THE LONG AXIS OF THE AAA WAS ANGLED BUT THE EXACT ANGLE WAS UNKNOWN. THE DELIVERY SYSTEM WAS ROTATED PER IFU. HOWEVER, THE ALTERNATIVE TRIGGER WIRE RELEASE METHOD WAS NOT UTILIZED AS PER LABELING. A 32 CODA BALLOON (UNAVAILABLE LOT NUMBER) WAS USED DURING THE PROCEDURE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 15573338 ↗
• MalfunctionMay 1, 2019Activation Problem; Activation Problem

  NO ADDITIONAL INFORMATION HAS BEEN RECEIVED REGARDING PATIENT AND/OR EVENT DETAILS SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8570744 ↗