China NMPA Product Recall - Implantable ECG event monitor (equipped with TruRhythm, model: LNQ11)

The National Medical Products Administration (NMPA) announced a Class II voluntary recall by Medtronic (Shanghai) Management Co., Ltd. on July 12, 2021. This recall targets all implantable ECG event monitors (model LNQ11, equipped with TruRhythm), registered under certificate number 20153121986. Medtronic identified a critical issue where these devices are susceptible to a partial electrical reset, occurring in 0.049% of units. This malfunction renders the monitors unable to automatically detect vital cardiac events like bradycardia and cardiac arrest, despite appearing operational via the programmer. The primary concerns arising from this defect include the potential for significantly delayed medical intervention, the risk of clinicians missing critical diagnoses, and the subsequent need for surgical removal and replacement of the affected implantable device. This situation underscores the importance of stringent device monitoring and swift corrective action. As of May 10, 2021, Medtronic confirmed that no adverse events, such as patient injury or fatalities, had been reported in connection with this specific issue. Medtronic's proactive voluntary recall demonstrates its adherence to the NMPA's framework for ensuring medical device safety and quality in China.