FDA-Device2016-06-22Class II

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

Cordis Corporation
Hazard

Inability to deploy the stent or partial stent deployment.

Sold states
NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
Affected count
4,400 units in US; 3,100 units to Foreign Countries
Manufactured in
14201 Nw 60th Ave, Miami Lakes, FL, United States
Products
Cordis PRECISE (R) RX Nitinol Stent System (Biliary)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1947-2016

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