China NMPA Product Recall - Thrombectomy stent

Stryker Neurovascular, through its affiliate Stryker (Beijing) Medical Devices Co., Ltd., initiated a voluntary Class II recall of its thrombectomy stents. This action, reported to the National Medical Products Administration (NMPA) on November 20, 2020, and published on November 23, 2020, was prompted by an increase in customer complaints regarding core wire breakage within specific models and batches of these critical medical devices. The primary issue identified is the potential for the thrombectomy stent to detach from its core wire during medical procedures. Such an occurrence poses a significant safety concern for patients, as it could compromise the intended therapeutic benefit and potentially lead to adverse events. Under the regulatory oversight of the NMPA, Stryker Neurovascular is recalling devices bearing Registration Certificate No.: 20203030002. The recall specifically targets affected product models, specifications, and batches, with further details provided in a "Medical Device Recall Event Report Form." This voluntary recall underscores the manufacturer's responsibility to address product safety concerns and adhere to regulatory standards for medical devices, prioritizing patient safety.