Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2099-2017 — Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indicated for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta (not including dissections) having vascular anatomy suitable for endovascular repair including: " I

U.S. FDA — Device Enforcement · United States · 2017-03-22 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2099-2017
Date of alert: 2017-03-22
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Cook Medical Incorporated
Product category: device
Product type: Devices

Reported risk: There have been five reports of graft thrombosis/occlusion during global commercial use, each following treatment for BTAI. One case resulted in patient death, and three cases resulted in reintervention.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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