China NMPA Product Recall - Subcutaneous implantable cardiac defibrillation electrode lead

On January 28, 2021, the National Medical Products Administration (NMPA) published an update regarding a voluntary product recall initiated by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. This action builds upon an initial recall report submitted on December 3, 2020. Boston Scientific is voluntarily recalling its manufactured subcutaneous implantable defibrillator leads, identified under Registration Certificate No.: 国械注进20153212409. The recall has been designated as a Level 1, signifying the highest level of recall seriousness, typically indicating a potential for serious adverse health consequences or death. While the specific defect or issue necessitating the recall is not detailed in the provided document, the company is taking this action to address concerns related to these critical medical device components. The regulatory framework overseeing this recall includes both the NMPA and the Shanghai Municipal Drug Administration. Detailed information regarding the specific models, specifications, and batches of the affected products is available in an attached "Medical Device Recall Event Report Form," indicating the required action is the removal of these devices from circulation to safeguard patient health.