Recall Z-1946-2016— Cordis Corporation

Class II · Terminated

Class II FDA medical device recall by Cordis Corporation, initiated 2016-05-04, terminated 2019-07-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid). Reason: Inability to deploy the stent or partial stent deployment..

Recalling firm
Cordis Corporation
Classification
Class II
Status
Terminated
Initiated
2016-05-04
Terminated
2019-07-26
Firm location
Miami Lakes, FL, United States

Product description

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

Reason for recall

Inability to deploy the stent or partial stent deployment.

Data sourced from openFDA. This site is unofficial and independent of the FDA.