China NMPA Product Recall - Disposable Prostate Steam Therapy Device (Rezum Delivery Device)

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Boston Scientific Corporation for its single-use prostate steam therapy device, the Rezum Delivery Device (National Medical Device Registration Certificate No. 20223090123). This recall, reported by Boston Scientific International Medical Trading (Shanghai) Co., Ltd., was prompted by a correction to previously released information concerning the device. The NMPA's announcement, dated November 29, 2024, clarifies that the products involved in this recall were not imported into China, thereby limiting direct impact on the Chinese market. This action falls under the regulatory oversight of the NMPA, ensuring compliance and public safety within the medical device industry. Detailed information regarding specific models, specifications, and batches is available in the associated "Recall Event Report Form." This proactive measure by Boston Scientific Corporation, guided by NMPA regulations, underscores the industry's commitment to addressing discrepancies and maintaining accurate product information to safeguard patient well-being.