FDA-Device2016-06-22Class II

Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)

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 and 3,100 units in Foreign Countries
Manufactured in
14201 Nw 60th Ave, Miami Lakes, FL, United States
Products
Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1946-2016

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