Cook Inc. Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Brand
Cook Inc.
Lot Codes / Batch Numbers
All lots. OUS distribution only, Product is not cleared or distributed in the USA.
Products Sold
All lots. OUS distribution only; Product is not cleared or distributed in the USA.
Cook Inc. is recalling Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft. due to The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to cu. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The firm has identified factors which contributed to failures relating to thrombus formation and/or lumen occlusion reports, and is highlighting to customers key points of the IFU pertaining to the prevention of these factors. In addition, the firm has updated the Planning and Sizing Worksheet to include associated information.
Recommended Action
Per FDA guidance
On January 14, 2020, the firm notified affected customers via Urgent Medical Device Correction letters/emails. Customers were advised to pay especial attention to several aspects of the Instructions for Use (IFU) which were of key importance when implanting a device. Customers were also provided with an updated Planning and Sizing Worksheet. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026