NMPA Reports Medical Device Recalls by Medtronic and Boston Scientific

Recently, the official website of the National Medical Products Administration released three medical device product recall notices.Many well-known medical device companies are also on the list. The specific information is as follows:

Medtronic (Shanghai) Limited reported that due to packaging seal issues, three batches of antegrade perfusion catheters may have sterility defects. The manufacturer, MEDTRONIC INC., has taken action regarding the products it produced.Antegrade Perfusion Cannula Cardioplegia Delivery Cannula(China Medical Device Registration No. 20153101305) voluntarily recalled. Recall level is Class II recall.

SEKISUI MEDICAL TECHNOLOGY (CHINA) LTD. reported that due to the change in product labeling information within Japan, the manufacturer SEKISUI MEDICAL CO., LTD. has made changes to its production.High-Density Lipoprotein Cholesterol Assay Kit (Direct Method) Cholestest N HDL(China Medical Device Registration No. 20162401433) Voluntary Recall. Recall Level: Class III Recall.

Boston Scientific International Medical Trading (Shanghai) Co., Ltd. reported that due to the reason of updating important information in the instructions, the manufacturer Boston Scientific Corporation has made changes to its production.ACURATE neo2™ Aortic Valve Transcatheter Implantation(China Medical Device Registration No. 20243130406),ACURATE neo2™ Transfemoral Delivery System for Transcatheter Implantable Aortic Valve(Registration No. 20243030548 for Medical Devices Imported into China) Voluntary Recall. Recall Level: Class III Recall.