China NMPA Product Recall - Radiofrequency ablation catheter

Boston Scientific Corporation has initiated a voluntary Class III recall of specific models and batches of its radiofrequency ablation catheters, as reported by Boston Scientific International Medical Trading (Shanghai) Co., Ltd. to the National Medical Products Administration (NMPA) in China. The recall, published on March 14, 2023, stems from the identification of inaccurate English instructions accompanying the affected medical devices. This issue pertains to products registered under National Medical Device Registration Certificate No. 20173015044. While the document does not detail specific inspection dates, it highlights the manufacturer's proactive measure to address a documentation discrepancy. The NMPA serves as the overseeing regulatory body for this action. The primary required action involves the systematic retrieval of the implicated radiofrequency ablation catheters from the market. Further comprehensive details regarding the specific models, specifications, and affected batches are documented in the "Medical Device Recall Event Report Form," which is referenced as an attachment to the official NMPA notice. This recall underscores the importance of precise product labeling and instructional accuracy within the medical device industry to ensure patient safety and proper device use.