Zenith Renu G55416Recalls & reported problems
Cook Incorporated · Zenith Renu, AAA Ancillary Graft Main Body Extension · Class 3 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002554167), received between May 3, 2018 and May 3, 2018 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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
Device problems
- Device Operates Differently Than Expected1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected
IT WAS REPORTED THE (B)(6) MALE PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO FIX A TYPE 1A ENDOLEAK FROM THE PRE-EXISTING GRAFT. AFTER THE SURGEON CUT DOWN AND GOT ACCESS FROM BOTH GROINS, THE LEFT SIDE WAS USED FOR IMPLANT OVER A LUNDERQUIST 300CM WIRE GUIDE. THE ZENITH RENU AAA ANCILLARY GRAFT MAIN BODY EXTENSION WAS ADVANCED OVER THE WIRE. THE SURGEON UNSHEATHED THE DEVICE, TOOK OFF THE FIRST TRIGGER WIRE, LOOSENED THE PIN VISE AND WHEN HE WENT TO ADVANCE THE INNER CANNULA HE COULD NOT REMOVE THE TOP CAP. THE VERY DISTAL (BLACK) PIECE ON THE CANNULA CAME OFF AND ADVANCED ALL THE WAY UP AND TOUCHED THE PIN VISE ALONG THE INNER CANNULA. THEY GRASPED THE CANNULA AND ADVANCED THE TOP CAP HOLDING ON TO THE INNER CANNULA. THE IMPLANT WAS SUCCESSFUL. THEY TOOK THE DISTAL TRIGGER WIRE OFF TO RETRIEVE THE TOP CAP WHICH WAS DIFFICULT. THE DILATOR WAS VERY HARD TO ADVANCE BUT THEY EVENTUALLY WERE ABLE TO RETRIEVE IT. THERE WERE NO ADDITIONAL PROCEDURES REQUIRED AS A RESULT OF THIS REPORTED ISSUE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7484933 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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