China NMPA Product Recall - Guidance tube

Boston Scientific Corporation has initiated a voluntary Class II recall of certain guiding tubes due to a manufacturing defect. The recall was reported by Stryker (Beijing) Medical Devices Co., Ltd. The core issue identified is an incorrect bending shape at the tip of specific models and batches of the guiding tubes. This defect could potentially impact the device's intended function and patient safety. The recall is being conducted under the oversight of the National Medical Products Administration (NMPA) of China, as indicated by the publication on their official website (Index No.: JGXX-2023-10041, Publication Date: 2023-03-14). The affected products are registered under National Medical Device Registration Certificate No. 20183661637. A Class II recall signifies that the use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. Boston Scientific Corporation is taking the necessary steps to address this issue, which involves removing the affected products from the market. Detailed information regarding the specific models, specifications, and batch numbers subject to this recall is available in the "Medical Device Recall Event Report Form" attachment, provided by Stryker (Beijing) Medical Devices Co., Ltd. This proactive measure aims to ensure product quality and patient safety within the medical device market.