Cook Inc. Recalls Zenith Alpha Spiral-Z Endovascular Leg Grafts
Cook Inc. is recalling Zenith Alpha Spiral-Z Endovascular Leg grafts due to identified factors contributing to thrombus formation and lumen occlusion. The product is distributed only outside the United States.
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 involves a medical device with reports of thrombus formation and lumen occlusion, which are serious health risks, but the source does not report specific injuries or deaths, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling the Zenith Alpha Spiral-Z Endovascular Leg, an endovascular graft with catalog prefix ZISL. The recall involves 68,241 units. The product is not cleared or distributed in the United States and was distributed worldwide to foreign markets.
The firm identified factors that contributed to reports of thrombus formation and/or lumen occlusion. To address these issues, the firm is highlighting key points in the Instructions for Use (IFU) regarding the prevention of these factors and has updated the Planning and Sizing Worksheet to include associated information.
Because the product is not distributed in the United States, U.S. consumers are not affected. Foreign customers should refer to the updated IFU and Planning and Sizing Worksheet provided by the manufacturer.
The recalled product
- Product
- Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
- Manufacturer
- Cook Inc.
- Affected units
- 68,241
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All lots. OUS distribution only
- Product is not cleared or distributed in the USA.
Distribution
Distribution scope not specified by the agency.
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