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Zenith Alpha G35329Recalls & reported problems

William Cook Europe ApS · Zenith Alpha, Thoracic Endovascular Graft, Proximal Component · Class 3 · Implant

All models of Zenith Alpha (67)

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 10827002353296), received between Nov 11, 2016 and Nov 11, 2016 — classified as 1 injury.

The most frequently reported specific device problem is “Occlusion Within Device” (1 report).

2 other recalls cover devices cleared under the same FDA submission (P140016); they may or may not involve this specific model.

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

  • Occlusion Within Device1

Patient problems

  • Thrombus1
  • Vascular Dissection1

Recent adverse event reports

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

  • InjuryNov 11, 2016Occlusion Within Device; Occlusion Within Device

    DESCRIPTION OF EVENT ACCORDING TO INITIAL REPORTER: THE INITIAL PROCEDURE WENT GREAT. AT THE ONE MONTH FOLLOW UP, EVERYTHING WAS FINE. AT SIX MONTHS THE PATIENT PRESENTED WITH LEG WEAKNESS AND A SIX MONTH FOLLOW UP CT SCAN WAS CONDUCTED. THE SCAN REVEALED AN ISSUE JUST BEYOND THE DISTAL EDGE OF THE GRAFT. THEY SUSPECT THIS ISSUE IS EITHER A DISSECTION OR CIRCUMFERENTIAL THROMBUS FORMATION. PATIENT OUTCOME: THEY ARE PLANNING A SECONDARY INTERVENTION TO RE-LINE AND EXTEND THE EXISTING GRAFT.

    Patient problems: Thrombus; Vascular Dissection

    MAUDE report 6095307 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P140016. One submission often covers many models, so check the product and lot details in each record.

  • Z-0043-2026 · Sep 18, 2025 · Open, Classified
    Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W ZTA2-P-40-217-W ZTA2-P-42-121 ZTA2-P-42-121-W
  • Z-2099-2017 · Mar 22, 2017 · Terminated
    Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descend

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