Cook Zenith Alpha Abdominal Endovascular Graft Recall for Damaged Bushing
Cook Inc. is recalling 571 units of Zenith Alpha Abdominal Endovascular Grafts due to a potential damaged bushing that may prevent full deployment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (inability to deploy a medical device) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Cook Inc. is recalling 571 units of the Zenith Alpha Abdominal Endovascular Graft, identified by catalog prefix ZIMB. The recall is due to a potential defect where the delivery system may contain a damaged bushing. This issue could result in difficulty or an inability to fully deploy the graft using the standard method described in the Instructions for Use (IFU).
The affected products were distributed to Canada, Chile, Argentina, Colombia, Great Britain, Austria, Belgium, the Czech Republic, Denmark, Spain, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Martinique, the Netherlands, Norway, Poland, Portugal, Serbia, South Africa, Sweden, the United Kingdom, Australia, Hong Kong, and Thailand. The recall covers specific catalog codes listed in the official FDA notice.
Healthcare providers and patients should contact Cook Inc. for further instructions regarding the affected devices. The recall is classified as Class II by the FDA, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Zenith Alpha Abdominal Endovascular Graft, Catalog Prefix ZIMB - Product Usage: is indicated for the endovascular treatment of patients with abdominal aortic or aorto-iliac aneurysms having morphology suitable for endovascular repair.
- Manufacturer
- Cook Inc.
- Affected units
- 571
Distribution
Distribution scope not specified by the agency.
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