Zenith Renu G55388Recalls & 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 10827002553887), received between Jan 5, 2022 and Jan 5, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Contamination” (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
- Contamination1
- Fluid/Blood Leak1
Patient problems
- Bacterial Infection1
- Pneumonia1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJan 5, 2022Contamination; Fluid/Blood Leak; Contamination; Fluid/Blood Leak
IT WAS REPORTED THAT AN ENDOLEAK AND BACTERIAL INFECTION OCCURRED ON A ZENITH RENU AAA ANCILLARY GRAFT CONVERTER FOLLOWING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. ON (B)(6) 2021, THE PATIENT WAS "CODING" DURING THE DEPLOYMENT OF THE GRAFT CONVERTER DEVICE. THE DEVICE WAS DEPLOYED LOWER IN THE ANATOMY THAN WAS PLANNED. ON (B)(6) 2021, AN ANGIOGRAM WAS COMPLETED THAT SHOWED AN ENDOLEAK. ON (B)(6) 2021, AN EXTENSION GRAFT WAS PLACED TO SEAL THE ENDOLEAK. IT WAS NOTED THE PATIENT HAD PNEUMONIA AND THAT THE GRAFT CONVERTER HAD A BACTERIAL INFECTION. THE GRAFT WAS SCHEDULED FOR EXPLANTATION ON (B)(6) 2021. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Patient problems: Bacterial Infection; Pneumonia
MAUDE report 13169784 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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