Recall of Cordis® S.M.A.R.T.® Flex Vascular Stent System sizes 5x200mm and 6x200mm due to deployment issues

Cardinal Health Singapore 225 Pte Ltd would like to inform healthcare professionals of the voluntary recall of all unexpired lots of Cordis^® S.M.A.R.T^® Flex Vascular Stent System sizes 5x200mm and 6x200mm. Based on complaints and subsequent investigation, Cordis has determined that affected devices have been associated with a higher frequency of deployment issues compared to other sizes. The most reported deployment difficulty is the inability to deploy the stent resulting in an intra-procedural delay while a replacement device is prepped. However, partial stent deployment may cause ischemia, or internal bleeding, which would require further intervention. Healthcare professionals are advised to return all unused affected devices to Cardinal Health Singapore. The recall is for deployment issues and does not affect S.M.A.R.T^® Flex stents successfully deployed. Please refer to letter for details.