China NMPA Product Recall - Disposable polyp removal device, disposable electric snare

Boston Scientific Corporation, through its subsidiary Boston Scientific International Medical Trading (Shanghai) Co., Ltd., initiated a voluntary Level II recall for specific models and batches of its disposable polyp removal devices and disposable electric snatch devices. This action, reported on August 18, 2020, was undertaken in accordance with the National Medical Products Administration (NMPA) guidelines in China. The primary issue identified was a "snatch cutting failure," which could prevent these medical devices from effectively cutting and removing polyps as intended. The affected products include disposable polyp removal devices (Registration Certificate Nos.: 20173220892, 20193011635) and disposable electric snatch devices (Registration Certificate No.: 20173256341). This recall emphasizes the company's commitment to patient safety and compliance with medical device regulations, ensuring that products meet performance standards. The detailed information regarding specific models and batches is available in the associated Medical Device Recall Event Report Form.