China NMPA Product Recall - Drug Delivery Embolisation System

The National Medical Products Administration (NMPA) announced a Class III voluntary recall initiated by Biocompatibles UK Limited for its Drug Delivery Embolisation System (Registration Certificate No.: 20193131949). This action, published on March 3, 2021, was reported by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. The primary reason for the recall stems from identified labeling errors affecting specific models and batches of the product. The NMPA's involvement, documented under Index No. JGXX-2021-10094, signifies adherence to medical device regulatory frameworks governing product safety and quality. A Class III recall indicates that the product issue, while a compliance concern, is unlikely to cause adverse health consequences. As part of the required actions, Biocompatibles UK Limited is voluntarily withdrawing the affected products from the market. Comprehensive details regarding the specific models, specifications, and impacted batches are available in the "Medical Device Recall Event Attachment: Medical Device Recall Event Report Form" referenced in the NMPA's announcement, ensuring transparency and providing necessary information for stakeholders to identify and manage affected units.