Skip to content

Zenith Renu G55386Recalls & reported problems

Cook Incorporated · Zenith Renu, AAA Ancillary Graft Converter · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002553863), received between Mar 19, 2015 and Mar 19, 2015 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (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

Device problems

  • Leak/Splash1

Patient problems

  • Other (for use when an appropriate patient code cannot be identified)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMar 19, 2015Leak/Splash

    THE DISTRICT MANAGER WAS CALLED IN TO THE FACILITY FOR AN EMERGENT RUPTURE ON A (B)(6) YEAR OLD FEMALE PATIENT. AFTER IMPLANTING THE DEVICE, A RUN WAS PERFORMED AND THE USER DISCOVERED A TYPE 3 ENDOLEAK. IT WAS NOTED THAT THERE WAS A TEAR IN THE FABRIC BETWEEN THE SECOND AND THIRD STENT. AN ADDITIONAL GRAFT WAS PLACED. THE FACILITY WILL KEEP A CLOSE EYE ON THE PATIENT AND BRING HER BACK ROUTINELY.

    Patient problems: Other (for use when an appropriate patient code cannot be identified)

    MAUDE report 4626988 ↗

Other SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices

All SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page