Cordis Corporation recalls Cordis PRECISE (R) RX Nitinol Stent System (Biliary)

Recall date

May 4, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1947-2016

FDA classification

Class II

Brand / firm

Cordis Corporation

Sold / distributed

NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.

Why it was recalled

Inability to deploy the stent or partial stent deployment.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Cordis PRECISE (R) RX Nitinol Stent System (Biliary)