China NMPA Product Recall - Implantable cardiac pacemaker

On June 14, 2023, the National Medical Products Administration (NMPA) released information concerning a voluntary Class III recall initiated by Boston Scientific International Medical Trading (Shanghai) Co., Ltd. This action was taken due to the misdistribution of a single implantable pacemaker, manufactured by Boston Scientific's Pacemaker Company, to a customer in Italy. The affected product, an implantable pacemaker with Medical Device Registration Certificate No. 20183120509, is the subject of this recall. While specific inspection dates are not detailed in the notice, the recall itself serves as a corrective measure under the regulatory framework of the NMPA. The Class III recall designation indicates that the use of, or exposure to, the misdistributed product is unlikely to cause adverse health consequences. Boston Scientific's required action is to retrieve the specified pacemakers, ensuring adherence to distribution protocols and maintaining product traceability and patient safety. Further specifics on affected models and batch numbers are provided in the company's Medical Device Recall Event Report Form.