FDAnews Device Daily Bulletin

China Department of Health Issues Stent System Device Alert

Feb. 7, 2012
Cordis stent defect leads to a field safety notice for its S.M.A.R.T. Control Nitinol stent system due to a potential sterility breach in the pouches of all unexpired lots. The Chinese Department of Health said the potential defect was detected during in-house testing on non-production product as part of a development project.