China NMPA Product Recall - Electrode transmission sheath

On September 15, 2023, Medtronic Inc., operating through its Medtronic (Shanghai) Management Co., Ltd. entity, initiated a voluntary Class II recall of its electrode delivery sheath. This action was announced under the regulatory oversight of the National Medical Products Administration (NMPA) and pertains to products registered under National Medical Device Registration No. 20173142128. The primary issue identified was an incorrect expiration date printed on the finished product labels of a specific model and batch of the electrode delivery sheath. This labeling error necessitated immediate corrective action to ensure product safety and regulatory compliance. As a required action, Medtronic Inc. is systematically recalling all affected units from the market. Comprehensive details regarding the specific models, specifications, and batch numbers subject to this recall are provided in the "Medical Device Recall Event Report Form." This proactive measure by Medtronic highlights its commitment to maintaining product integrity and adhering to the stringent quality and safety standards mandated by the NMPA, mitigating any potential risks associated with inaccurate labeling.