Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Biosensors Europe SA BioFreedom Ultra Drug Coated Coronary Stent System [Model Numbers: BFC1-2524, BFC1-2529; Lot Numbers: W22080244Z, W22100016Z] [HKMD No.: 220250].
According to the manufacturer, Biosensors became aware that in some BioFreedom Ultra Drug Coated Coronary Stent System (DCS) products the information provided on the country specific label does not match that provided on the manufacturer’s original label (which is correct and matches the products specifications). This issue was identified during the label scanning of a consignment stock check in Brazil.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 21 May 2024