Field Safety Notice: Cordis - Cordis PRECISE® PRO RX Nitinol Stent System

donderdag 19 mei 2016 11:00

Based on recent complaints and subsequent investigation, Cordis has determined that products made between April 27, 2015 and November 22, 2015 (lots in Table 1) have been associated with an increased frequency of incidents of deployment difficulty and in some instances outer member shaft separation resulting in inability to deploy the stent or partial stent deployment.