Cook recalls Zenith Alpha Spiral-Z Endovascular Leg grafts (catalog prefix ZISL) due to potential thrombus formation and lumen occlusion risks. Product not distributed in the USA.
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.
Cook is recalling its Zenith Alpha Spiral-Z Endov:vascular Leg grafts (catalog prefix ZISL) because they may cause blood clots or blockages. This product is not sold in the U.S. and was distributed outside the country only.
The grafts may form blood clots or block blood flow in the leg, which could lead to complications. The manufacturer has updated instructions to help prevent these issues but the product is not approved for U.S. use.
Patients who received this endovascular graft during procedures outside the U.S. are affected. The product is not cleared or distributed in the U.S., so no U.S. patients are at risk.
Check for the catalog prefix ZISL on the product label. This endovascular graft was only distributed outside the U.S. and not cleared for use in the United States.
Look for the catalog prefix ZISL on the endovascular graft label.
No, this product is not cleared or distributed in the United States.
The manufacturer identified risks of blood clots or blockages in the leg from this graft type.
Since this product is not distributed in the U.S., no U.S. patients are affected. Check your label for the catalog prefix ZISL if you received it outside the U.S.
We’ve drafted a message you can send Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1355-2020 — Cook Cook Hello, I own a Cook that is covered by recall Z-1355-2020 from Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
