China NMPA Product Recall - Programmer/Recorder/Monitor

On September 19, 2019, the National Medical Products Administration (NMPA) issued a notice regarding a voluntary recall initiated by Cardiac Pacemakers Incorporated, a wholly owned subsidiary of Guidant Corporation, which is itself a wholly owned subsidiary of Boston Scientific Corporation. Boston Scientific International Medical Trade (Shanghai) Co., Ltd. was also involved in the publication of this recall. The recall pertains to their Programmer/Recorder/Monitor controllers, identified by Registration Certificate No.: 20173216548. The primary issue necessitating this action is attributed to potential software misconfiguration problems within the affected devices. Given the potential impact on patient safety, this recall has been classified as Level 1, indicating a high risk of serious adverse health consequences or death. As a required action, the company is undertaking a comprehensive voluntary recall of specific models, specifications, and batches of these controllers. Further detailed information regarding the affected product units is provided in an accompanying "Medical Device Recall Event Report Form." This action underscores the manufacturer's commitment to addressing identified product deficiencies under the regulatory guidance of the NMPA, ensuring the safety and efficacy of medical devices in the market.