China NMPA Product Recall - Drug infusion system

The National Medical Products Administration (NMPA) published details on December 29, 2016, concerning a voluntary market corrective action by Medtronic (Shanghai) Management Co., Ltd. for its SynchroMed II drug infusion systems. The recall began in March 2014 when Medtronic, Inc., the manufacturer, identified that these devices might cause an overdose, defined as an infusion rate exceeding the programmed rate by more than 14.5%. This malfunction could lead to patients receiving less medication than expected during pump reperfusion.

In November 2016, Medtronic submitted new findings regarding the root causes of these pump malfunctions and communicated these updated investigation results to authorities and customers. As a continuation of the initial action, Medtronic intends to send updated letters to users, providing comprehensive information on malfunction factors, incidence rates, and revised patient management recommendations. Notably, the company does not advise the precautionary removal of existing SynchroMed II pumps, and this corrective action does not require the return of affected products. Sales of the SynchroMed II system in China were discontinued following the expiration of its registration certificate on November 30, 2014, with a new certificate pending.