China NMPA Product Recall - Guidewire (product name: Synchro & Synchro2)

Boston Scientific, Inc., along with its Chinese affiliate, Boston Scientific International Medical Trade (Shanghai) Co., Ltd., initiated a recall for their Synchro and Synchro2 guidewires. This action followed an internal inspection that identified a manufacturing defect where polytetrafluoroethylene (PTFE) coating fragments could detach from the guidewires. These free-floating particles, potentially up to 4200 micrometers, pose a risk of ischemic stroke if they enter the cerebral circulation. Although no related complaints or adverse event reports had been received, the recall was a proactive measure to ensure patient safety across affected regions, including China.

The recall was conducted under the regulatory framework of China's National Medical Products Administration (NMPA), as documented in a Medical Device Recall Event Report Form. Required actions included identifying all affected customers based on shipping history, disseminating official notifications via mail, fax, and direct visits, and arranging for the return of the non-conforming products. Boston Scientific set an anticipated completion date for these corrective actions as September 5, 2010.