China NMPA Product Recall - microcatheter

Boston Scientific Corporation initiated a voluntary Class III recall of specific models and batches of its microcatheters, as reported by its subsidiary, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. The National Medical Products Administration (NMPA) publicly announced this action on March 26, 2021. The recall addresses significant labeling and packaging errors identified in the affected medical devices. Boston Scientific Corporation, the manufacturer, proactively reported these discrepancies to the NMPA. This voluntary recall aims to mitigate any potential risks associated with the identified errors, although a Class III designation generally implies that exposure to the violative product is unlikely to cause adverse health consequences. The NMPA's public disclosure highlights its role in regulatory oversight and ensuring transparency in medical product safety within China. Further details regarding the specific affected product models, specifications, and batch numbers are contained within the official "Medical Device Recall Event Report Form."