FDA Medical Device Recalls (openFDA)
Cook Inc.: Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
- Recall number
- Z-1355-2020
- Recalling firm
- Cook Inc.
- Product
- Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
- Status
- Terminated
- Initiated
- 2020-01-16
- Posted
- 2020-01-31
- Terminated
- 2020-11-12
- Reason
- 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.
- Root cause
- Labeling design
- Action
- 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.
- Quantity
- 68,241
- Distribution
- Foreign distribution only. Distributed worldwide.
- Lot, serial or model codes
- All lots. OUS distribution only; Product is not cleared or distributed in the USA.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MIH
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28