China NMPA Product Recall - microguidewires

Balt Extrusion SAS, a medical device manufacturer, in collaboration with its subsidiary Balt Extrusion (Beijing) Co., Ltd., has initiated a voluntary recall of its guidewires. This action, publicized by the National Medical Products Administration (NMPA) on December 1, 2025, addresses a critical safety concern identified with the HYBRID007D guidewire model. The primary issue reported is excessive friction occurring between the guidewire and microcatheter during clinical use, which could potentially impact patient safety or procedural outcomes. The recall has been classified as Class III, signifying that the use of or exposure to the affected product is not likely to cause severe adverse health consequences. This decision aligns with the regulatory oversight of the NMPA, which granted the National Medical Device Registration Certificate No. 20213030208 for the product. Comprehensive details regarding the specific models, specifications, and batch numbers involved in this recall are provided in the official "Medical Device Recall Event Report Form" and its attachment. This proactive measure by Balt Extrusion SAS highlights their dedication to product safety and adherence to national medical device regulations.