China NMPA Product Recall - Covered scaffold system

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of its covered stent systems, as announced by the National Medical Products Administration (NMPA) on January 18, 2022. This action pertains to specific batches of products (Registration Certificate Nos.: 20153132422; 20173137035). The recall was triggered by a complaint investigation which revealed that the conical tip of certain stent systems could detach from the delivery mechanism during surgical deployment. Further inquiry identified the root cause as improper handling by a supplier's personnel during the manufacturing of the conical tip assembly. The estimated incidence of this issue is very low at 0.002%. As of December 9, 2021, five global complaints regarding tip separation were received, with no reported adverse events in the Chinese market. Medtronic determined that patients who had the stent successfully deployed face no additional risk or require further measures. Under the NMPA's regulatory framework, the company's required action is to recall the affected product models and batch numbers, with detailed information available in the "Medical Device Recall Event Report Form."