China NMPA Product Recall - Artificial blood vessel patch

The National Medical Products Administration (NMPA) has announced a Class II voluntary recall by manufacturer InterVascular SAS, reported by Maikewei (Shanghai) Medical Equipment Co., Ltd. The recall notice, dated April 17, 2025, pertains to artificial blood vessel patches, specifically 'Vascular Patches' (National Medical Device Registration Certificates 20173137193 and 20173467193). The primary reason for this action is the inadequate description of the inner and outer surfaces of these medical devices. Such lack of clarity could potentially lead to incorrect application or improper use, thereby posing a risk to patient safety. Under the NMPA's regulatory framework, a Class II recall signifies that the product's use or exposure might cause temporary or medically reversible adverse health consequences, or where the probability of serious harm is remote. As a corrective measure, InterVascular SAS is voluntarily withdrawing the affected product models from the market. A key detail to note is that the specific products subject to this recall were not imported into China. Further detailed information regarding the models and specifications is available in the official Medical Device Recall Event Report Form.