China NMPA Product Recall - Programmable controller

Sorin Medical (Shanghai) Co., Ltd., acting on behalf of manufacturer SORIN GROUP ITALIA S. R. L., initiated a Class I voluntary recall for its Programmable Controllers. This action was reported to the National Medical Products Administration (NMPA) on October 11, 2016, and publicly announced on December 7, 2016. The primary issue identified was that the programmers were overestimating the remaining lifespan of certain pacemakers and displaying incorrect values, a critical flaw given their function in querying, programming, and testing pulse generators. While these devices, registered under NMPA Approval No. 3214679, are not sold in China, 148 units were loaned to hospitals. The regulatory framework governing this action is the NMPA's medical device recall process. As a required action, Sorin Medical implemented a corrective measure involving a software upgrade for all affected programmers. Technical sales personnel were dispatched to visit each hospital where the controllers were distributed to perform the necessary software updates and ensure users were properly informed, thereby mitigating potential patient safety risks associated with inaccurate pacemaker data.