Zenith Alpha Thoracic Endovascular Graft The Zenith Alpha" Thoracic Endovascular Graft is indi...
FDA Device Recall #Z-2099-2017 — Class I — March 22, 2017
Recall Summary
| Recall Number | Z-2099-2017 |
| Classification | Class I — Serious risk |
| Date Initiated | March 22, 2017 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Cook Medical Incorporated |
| Location | Bloomington, IN |
| Product Type | Devices |
| Quantity | 4916 |
Product Description
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: " Iliac/femoral anatomy that is suitable for access with the required introduction systems, " Nonaneurysmal aortic segments (fixation sites) proximal and distal to the thoracic lesion: " with a length of at least 20 mm, and " with a diameter measured outer wall to outer wall of no greater than 42 mm and no less than 15 mm.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution.
Lot / Code Information
All lots. Catalog Numbers: ZTA-D-28-160-W ZTA-D-28-229-W ZTA-D-30-160-W ZTA-D-30-229-W ZTA-D-32-160-W ZTA-D-32-229-W ZTA-D-34-142-W ZTA-D-34-190-W ZTA-D-36-142-W ZTA-D-36-190-W ZTA-D-38-147-W ZTA-D-38-197-W ZTA-D-40-147-W ZTA-D-40-197-W ZTA-D-42-152-W ZTA-D-42-204-W ZTA-D-44-157-W ZTA-D-44-211-W ZTA-D-46-157-W ZTA-D-46-211-W ZTA-DE-18-104-W ZTA-DE-18-148-W ZTA-DE-20-104-W ZTA-DE-20-148-W ZTA-DE-22-104-W ZTA-DE-22-148-W ZTA-DE-24-104-W ZTA-DE-24-148-W ZTA-DE-26-104-W ZTA-DE-26-148-W ZTA-DE-28-108-W ZTA-DE-28-154-W ZTA-DE-30-108-W ZTA-DE-30-154-W ZTA-DE-32-108-W ZTA-DE-32-154-W ZTA-DE-34-112-W ZTA-DE-34-160-W ZTA-DE-36-112-W ZTA-DE-36-160-W ZTA-DE-38-141-W ZTA-DE-38-91-W ZTA-DE-40-141-W ZTA-DE-40-91-W ZTA-DE-42-146-W ZTA-DE-42-94-W ZTA-DE-44-151-W ZTA-DE-44-97-W ZTA-DE-46-151-W ZTA-DE-46-97-W ZTA-P-18-105-W ZTA-P-18-127-W ZTA-P-20-105-W ZTA-P-20-127-W ZTA-P-22-105-W ZTA-P-22-127-W ZTA-P-24-105-W ZTA-P-24-127-W ZTA-P-26-105-W ZTA-P-26-149-W ZTA-P-28-109-W ZTA-P-28-132-W ZTA-P-28-155-W ZTA-P-28-201-W ZTA-P-30-109-W ZTA-P-30-132-W ZTA-P-30-155-W ZTA-P-30-201-W ZTA-P-32-109-W ZTA-P-32-132-W ZTA-P-32-155-W ZTA-P-32-201-W ZTA-P-34-113-W ZTA-P-34-137-W ZTA-P-34-161-W ZTA-P-34-209-W ZTA-P-36-113-W ZTA-P-36-137-W ZTA-P-36-161-W ZTA-P-36-209-W ZTA-P-38-117-W ZTA-P-38-142-W ZTA-P-38-167-W ZTA-P-38-217-W ZTA-P-40-117-W ZTA-P-40-142-W ZTA-P-40-167-W ZTA-P-40-217-W ZTA-P-42-121-W ZTA-P-42-147-W ZTA-P-42-173-W ZTA-P-42-225-W ZTA-P-44-125-W ZTA-P-44-152-W ZTA-P-44-179-W ZTA-P-44-233-W ZTA-P-46-125-W ZTA-P-46-152-W ZTA-P-46-179-W ZTA-P-46-233-W ZTA-PT-22-18-105-W ZTA-PT-26-22-105-W ZTA-PT-30-26-108-W ZTA-PT-32-28-178-W ZTA-PT-32-28-201-W ZTA-PT-34-30-161-W ZTA-PT-34-30-209-W ZTA-PT-36-32-161-W ZTA-PT-36-32-209-W ZTA-PT-38-34-167-W ZTA-PT-38-34-217-W ZTA-PT-40-36-167-W ZTA-PT-40-36-217-W ZTA-PT-42-38-173-W ZTA-PT-42-38-225-W ZTA-PT-44-40-179-W ZTA-PT-44-40-233-W ZTA-PT-46-42-179-W ZTA-PT-46-42-233-W
Other Recalls from Cook Medical Incorporated
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0043-2026 | Class I | Zenith Alpha 2 Thoracic Endovascular Graft, Cat... | Sep 18, 2025 |
| Z-1833-2024 | Class II | EchoTip¿ Ultra Endoscopic Ultrasound Access Nee... | Apr 1, 2024 |
| Z-1832-2024 | Class II | EchoTip¿ Ultra HD Endoscopic Ultrasound Access ... | Apr 1, 2024 |
| Z-0876-2022 | Class III | Cook Celect PlatinumVena Cava Filter Set Catal... | Feb 14, 2022 |
| Z-0875-2022 | Class III | Gunther Tulip Vena Cava Filter Set for Femoral ... | Feb 14, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.