China NMPA Product Recall - Reveal LINQ™ Implantable Cardiac Event Monitor (ICM) (Model: LNQ11)

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall for its Reveal LINQ™ Implantable ECG Event Monitors (ICM), Model LNQ11. The recall report, dated March 4, 2016, was publicly announced by the National Medical Products Administration (NMPA) on April 21, 2016. The primary concern revolves around a performance issue where the device's Recommended Replacement Time (RRT) alarms may not function as intended. These monitors are crucial implantable detection systems used for recording subcutaneous electrocardiograms in patients at risk of or experiencing transient symptoms of arrhythmia. The recall affects all batch numbers of the LNQ11 model globally, with 143 units specifically imported into China. Medtronic Inc. is the manufacturer, and Medtronic (Shanghai) Management Co., Ltd. is the responsible entity in China for managing the recall. The required action involved dispatching formal notification letters via express mail to all identified affected medical institutions, ensuring they were promptly informed about the potential performance anomaly and the necessary steps to address it, thereby maintaining patient safety and regulatory adherence.