China NMPA Product Recall - Diffused braided artificial blood vessels

Maikewei (Shanghai) Medical Equipment Co., Ltd. has initiated a voluntary Class II recall of its difibril-woven artificial blood vessels, as documented by the National Medical Products Administration (NMPA) on March 30, 2020. The recall stems from multiple complaints received between July 2018 and September 2019, reporting intraoperative bleeding at the anastomosis site of the artificial blood vessel branches. While these incidents caused surgical delays, it was noted that they did not impact the overall surgical process or its ultimate consequences. To uphold patient safety and ensure responsible product use, the company proactively decided to withdraw the affected medical devices from the market. The recall pertains to specific models, specifications, and batches of products registered under certificate number 国械注进20173460601, with detailed information available in an accompanying Medical Device Recall Event Report Form. This action underscores the manufacturer's commitment to maintaining product integrity under the regulatory oversight of the NMPA.