China NMPA Product Recall - Extractor Pro RX Retrieval Balloon Catheter

Boston Scientific Corporation, through its reporting entity Boston International Medical Trading (Shanghai) Co., Ltd., announced a voluntary Class II recall concerning its Stone Removal Balloon Catheter, specifically the Extractor Pro RX Retrieval Balloon Catheter (National Medical Device Registration Certificate No. 20162024492). This recall, published by the National Medical Products Administration (NMPA) on September 24, 2025, under index number JGXX-2025-10129, addresses a critical issue: the incorrect marking of the contrast agent injection site in a specific manufacturing batch. Such an error could potentially lead to improper use of the device or complicate medical procedures if not identified, highlighting the importance of precise product labeling in medical devices. The Class II designation indicates that while the issue presents a potential for temporary or medically reversible adverse health consequences, the probability of serious adverse health consequences is remote. It is important to note that the specific products involved in this recall were not imported into China, mitigating direct impact on the Chinese market. Boston Scientific is actively managing this product discrepancy to ensure patient safety and product integrity globally.