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Lower risk Medical device recall · FDA · Published January 16, 2020

Cook Zenith Alpha Spiral-Z Endovascular Leg Recall: Thrombus Risk

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.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1355-2020Medical deviceCook ›
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Contact the company

Recalling firmCook Inc.750 N Daniels Way · Bloomington, IN 47404-9120
✎ GovInfoNow plain-language explainer

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. Read more at govinfonow.com/recall/65988-cook-zenith-alpha-spiral-z-endovascular-leg-recall-thrombus-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/65988-cook-zenith-alpha-spiral-z-endovascular-leg-recall-thrombus-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1355-2020

Cite this page

“Cook Zenith Alpha Spiral-Z Endovascular Leg Recall: Thrombus Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/65988-cook-zenith-alpha-spiral-z-endovascular-leg-recall-thrombus-risk. Based on FDA recall #Z-1355-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1355-2020%22&limit=1).

The FDA announced on Jan. 16, 2020, that Cook Inc. is recalling Zenith Alpha Spiral-Z Endovascular Leg grafts with catalog prefix ZISL due to thrombus formation and lumen occlusion risks. The firm has updated the Planning and Sizing Worksheet to address these issues.

How to tell if you have it

  • Brand: Cook
  • Product: Zenith Alpha Spiral-Z Endovascular Leg
  • Catalog Prefix: ZISL
  • Quantity: 68,241 units

The hazard

The recall addresses failures relating to thrombus formation and/or lumen occlusion. The firm is highlighting key points in the Instructions for Use (IFU) regarding the prevention of these factors.

Context

GovInfoNow's records show Cook Inc. has issued 38 other recalls since July 31, 2017. Recent Cook recalls include the Nov. 12, 2021, Flexor Check-Flo Introducer Ansel Modification recall for mislabeling risk and the Oct. 13, 2021, Skinny Needle with Chiba Tip Recall for black debris risks. Other recent recalls of similar products include the Cook Ring Transjugular Intrahepatic Access Sets Recall (Nov. 26, 2025) and the Wilson-Cook Instinct Plus Endoscopic Clipping Device Recall (March 3, 2026).

How to tell if you have this one

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.

  • Brand
    Cook
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the catalog prefix ZISL on the endovascular graft label.

How this recall unfolded

Recall timeline

FDA terminated this recall 10 months after the firm started it.

1. Firm started the recall: Jan 16, 202012. FDA classified it Class II: Feb 24, 202023. Published in FDA’s Enforcement Report: Mar 4, 202034. FDA terminated the recall: Nov 12, 202042020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

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.

  • Official source: FDA Recall #Z-1355-2020 (January 16, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1355-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA