China NMPA Product Recall - Implantable Cardiac Resynchronization Therapy Defibrillator; Implantable Cardioverter Defibrillator

Boco International Medical Trade (Shanghai) Co., Ltd. initiated a voluntary Class III recall on December 5, 2019, for specific models of their Implantable Cardiac Resynchronization Therapy Defibrillators and Implantable Cardioverter-Defibrillators. This action followed a report detailing an additional, unauthorized laser marking observed on the casing of a device during an implantation procedure.An internal investigation by the company confirmed that, despite this additional marking, the affected machine's overall performance met factory specifications, and it possessed a complete historical record. Crucially, no other related complaints or adverse events have been reported concerning this particular issue.Operating under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, Boco International Medical Trade is undertaking this recall to address the deviation from standard product specifications. The recall decision, referenced under Shanghai Food and Drug Administration Medical Device Decision No. 2019-295, requires the company to retrieve the affected products from the market. Further detailed information regarding specific models, specifications, and batch numbers is provided in an accompanying "Medical Device Recall Event Report Form." This proactive measure aims to ensure product integrity and adherence to regulatory standards for medical devices.