China NMPA Product Recall - Covered stent system, covered stent balloon catheter

Medtronic Inc., through its agent Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary Class II recall, reported to China's National Medical Products Administration (NMPA) on May 9, 2019, with the NMPA publishing the notification on May 16, 2019. The recall concerns Medtronic Covered Stent Systems (Registration Certificate No. 20153462422) and Covered Stent Balloon Catheters (Registration Certificate No. 20173771836).

The issue stemmed from a procedural error originating in Canada, where a commercial order containing specific product models, including ETUF3614C102EE, ETLW1616C124EE, AB46, and OCL24, was incorrectly processed as a demonstration order and sent to a hospital. A significant violation involved the OCL24 model, which lacks a registration certificate in China; its sterile packaging was compromised and it was labeled "Not for Human Use" before shipment. Subsequently, three of these products were implanted in one patient, though no patient harm has been reported.

Under the NMPA regulatory framework, Medtronic reported this event. However, since no affected products were sold within China, no further corrective actions are required in China. The company confirmed that this incident does not affect other product categories.