FDA recall Z-1355-2020

Product

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

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.

Distribution

Foreign distribution only. Distributed worldwide.

Key facts

Status

Terminated

Initiation date

2020-01-16

Report date

2020-03-04

Termination date

2020-11-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1355-2020