Skip to content

Zenith G29869Recalls & reported problems

Cook Incorporated · Zenith, AAA Main Body Graft · Class 3 · Implant

Data updated Oct 16, 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 10827002298696), received between Nov 3, 2017 and Nov 3, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Partial Blockage” (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

  • Partial Blockage1

Patient problems

  • Thrombus1

Recent adverse event reports

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

  • MalfunctionNov 3, 2017Partial Blockage; Partial Blockage

    IT WAS REPORTED THAT A ZENITH ILIAC BRANCH GRAFT SYSTEM STUDY PATIENT UNDERWENT AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE WITH A ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY ENDOVASCULAR GRAFT ILIAC LEG. THERE WAS NO REPORTED DIFFICULTY DEPLOYING ANY OF THE DEVICES. A MOLDING BALLOON WAS NOT USED. POST STENT DILATATION WAS PERFORMED ON ANOTHER MANUFACTURER'S STENT. ANGIOGRAPHY REVEALED PATENT DEVICES WITH NO KINK OR ENDOLEAK. CORE LAB EVALUATION REVEALED PATENT DEVICES WITHOUT KINK OR ENDOLEAK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2016 (1-DAY POST-PROCEDURE). FOLLOW-UP IMAGING WAS PERFORMED ON (B)(6) 2016 (27 DAYS POST-PROCEDURE) VIA COMPUTERIZED AXIAL TOMOGRAPHY (CT) SCAN. DEVICES WERE REPORTEDLY PATENT AND INTACT WITH NO KINK HOWEVER, TYPE II ENDOLEAK WAS NOTED. THE PATIENT WAS STARTED ON ASPIRIN THERAPY ON (B)(6) 2017. ADDITIONAL FOLLOW-UP IMAGING WAS PERFORMED ON (B)(6) 2017 (202 DAYS POST-PROCEDURE) VIA CT SCAN. AGAIN, DEVICES WERE REPORTEDLY PATENT WITH NO KINK OR ENDOLEAK. THROMBUS FORMATION WAS NOTED IN THE DISTAL RIGHT COMMON ILIAC LIMB, THE LEFT INTERNAL ILIAC AND THE LEFT COMMON ILIAC. ON THE SAME DATE, THE PATIENT WAS STARTED ON PLAVIX. THE TREATING PHY

    Patient problems: Thrombus

    MAUDE report 7001322 ↗

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