—#179350

Product

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

FDA product code: MIH — System, Endovascular Graft, Aortic Aneurysm Treatment
Device class: Class 3
Medical specialty: Unknown
Affected lot / code info: All lots. OUS distribution only; Product is not cleared or distributed in the USA.

Why it was recalled

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 (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: Foreign distribution only. Distributed worldwide.

Timeline

Recall initiated: 2020-01-16
Posted by FDA: 2020-01-31
Terminated: 2020-11-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #179350. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.