China NMPA Product Recall - Tiered-therapy Cardioverter/Defibrillator

The National Medical Products Administration (NMPA) announced on February 19, 2020, a Class III voluntary recall initiated by St. Jude Medical Coordination Center BVBA (St. Jude Medical Products Belgium Ltd.). This recall, reported by Abbott Medical Products (Shanghai) Co., Ltd., concerns specific models and batches of implantable cardioverter/defibrillators, including those with Registration Certificate Nos. 20153212692 and 20153212693. The primary issue identified is a potential loss of wireless radio frequency (RF) communication, which could lead to an interruption in essential remote monitoring and data transmission capabilities of these devices. The recall highlights a critical safety concern where patients relying on these implantable devices for cardiac therapy might not have their device's performance remotely monitored effectively, potentially delaying detection of critical events or device malfunctions. The regulatory oversight for this action falls under the NMPA, which is responsible for ensuring the safety and efficacy of medical devices in China. St. Jude Medical Coordination Center BVBA is taking the required action of voluntarily recalling the affected Tiered-therapy Cardioverter/Defibrillator products. Further specific details regarding the impacted product models, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This proactive measure aims to mitigate potential risks associated with the communication failure, ensuring patient safety and device reliability.