China NMPA Product Recall - Drug infusion system

Medtronic Inc., through its Medtronic (Shanghai) Management Co., Ltd. entity, initiated a voluntary Class III recall of specific drug infusion systems, as reported by the National Medical Products Administration (NMPA) on January 10, 2020. This action stems from the discontinuation of certain models of these products in 2017. The primary concern prompting the recall is to ensure that patients who have previously received these implanted devices can continue to access necessary treatment and support, thereby preventing any disruption to their ongoing medical care due to the product's discontinuation.The recall is managed under the regulatory oversight of the NMPA, referencing Registration Certificate No.: CFDA (Imported) No. 20103543342 (Revised). While specific inspection dates are not detailed, the January 10, 2020, publication date serves as the regulatory notification for this event. A Class III recall typically indicates a situation where the use of or exposure to the product is not likely to cause adverse health consequences. Required actions involve the systematic voluntary recall of the affected drug infusion systems to address the continuity of care for implanted patients. Detailed information regarding specific models, specifications, and batches is available in the associated "Medical Device Recall Event Report Form."