Z-1355-2020Class II

Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft

Name: Z-1355-2020 Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft
Creator: Cook Inc.
Published: 2020-01-16
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2020-01-16 / Terminated / root cause: labeling and UDI

FDA source

Cook Inc. began a recall of Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft on 2020-01-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1355-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-16
Posted: 2020-01-31
Terminated: 2020-11-12
Recalling firm: Cook Incorporated
Product: Zenith Alpha Spiral-Z Endovascular Leg, Catalog Prefix ZISL. The product is an endovascular graft.
Product code: MIH System, Endovascular Graft, Aortic Aneurysm Treatment
Reason for recall: 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 tag: labeling and UDI
FDA 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 in commerce: 68,241
Distribution: Foreign distribution only. Distributed worldwide.
Product codes and lots: All lots. OUS distribution only; Product is not cleared or distributed in the USA.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1355-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1355-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-24

Product code MIH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)