China NMPA Product Recall - Implantable neurostimulation system extension lead kit

The National Medical Products Administration (NMPA) announced a voluntary Class III recall initiated by Abbott Medical, as reported by Abbott Medical Products (Shanghai) Co., Ltd. The recall, published on April 3, 2025, is due to modifications made to product labels and instructions for several implantable neurostimulation systems. The affected products include various Implantable Neurostimulation System Extension Lead Kits (Registration No. 20173125193), Implantable Neurostimulation System Percutaneous Leads Kits (Registration No. 20173126226), and Implantable Neurostimulation System Lamitrode (Surgical) Leads Kits for ANS Neurostimulators. Additionally, the Implantable Medical Device Recall System (Registration No. 20173126379) and the Implantable Spinal Cord Neurostimulation System (Registration No. 20213120264) are part of this action. This voluntary measure addresses updates in product information; notably, the specific models and batches involved were not imported into China. Detailed information is available in the accompanying Medical Device Recall Event Report Form. The NMPA oversees this regulatory action to ensure adherence to medical device standards.