China NMPA Product Recall - Radiofrequency ablation catheter

The National Medical Products Administration (NMPA) announced on July 26, 2023, that Boston Scientific Corporation initiated a voluntary Class III recall of its radiofrequency ablation catheters. This action was reported by Boston Scientific International Medical Trading (Shanghai) Co., Ltd., which acts as the distributor. The recall pertains to products registered under National Medical Device Registration Certificate No. 20173015044.The primary reason for the recall stems from a significant compliance issue: inconsistent information found in promotional materials regarding the approved indications for the catheters. This discrepancy means that the marketing content did not accurately reflect the uses for which the device received regulatory clearance, potentially misleading healthcare professionals or patients about its scope of application.Under the NMPA's regulatory framework, manufacturers are required to ensure all promotional and marketing materials precisely align with their product's official registration and approved indications. The voluntary recall signifies the company's commitment to addressing this non-compliance. Affected product models, specifications, and batch numbers are detailed in an attached Medical Device Recall Event Report Form, ensuring transparency and facilitating the efficient retrieval of the devices from the market. This measure aims to safeguard public health by ensuring medical devices are marketed and used strictly according to their approved parameters.