Cook Medical Recalls Zenith Alpha Thoracic Endovascular Grafts
Cook Medical is recalling Zenith Alpha Thoracic Endovascular Grafts due to reports of graft thrombosis and occlusion, including one patient death.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states that one case resulted in patient death, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
Cook Medical Incorporated is recalling the Zenith Alpha Thoracic Endovascular Graft, a medical device used for the endovascular treatment of patients with isolated lesions of the descending thoracic aorta. The recall covers 4,916 units distributed nationwide.
The recall was initiated following five reports of graft thrombosis or occlusion during global commercial use, each occurring after treatment for BTAI (Bleeding Thoracic Aortic Injury). One of these cases resulted in patient death, and three cases required reintervention.
Patients who have received this device should contact their healthcare provider for guidance on monitoring and potential follow-up care. The recall applies to all lots of the affected catalog numbers.
The recalled product
- Product
- 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…
- Manufacturer
- Cook Medical Incorporated
- Category
- Medical Device — Vascular Graft
- Affected units
- 4,916
Distribution
Distributed nationwide across the United States.
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