China NMPA Product Recall - Trevo XP ProVue Retriever Thrombectomy Stand

Stryker Neurovascular initiated a voluntary Level III recall of its Trevo XP ProVue Retriever thrombectomy stent, identified under NMPA Index No. JGXX-2021-10555. The recall, reported by Stryker (Beijing) Medical Devices Co., Ltd., was announced on October 15, 2021, and concerns specific models and batches of the device (Registration Certificate No.: 20203030002). The primary issue prompting this action was the discovery that some products, specifically those shipped to Saudi Arabia, did not contain the most current instructions for use. These outdated instructions differed significantly from the latest version regarding the product's intended scope of application. This discrepancy could potentially lead to off-label use or misunderstanding of the device's capabilities and limitations by healthcare professionals. As a corrective measure, Stryker Neurovascular is voluntarily recalling the affected thrombectomy stents. Further details regarding the precise models, specifications, and batch numbers involved are documented in the "Medical Device Recall Event Report Form" attached to the official NMPA notice. This action underscores the manufacturer's commitment to ensuring product safety and adherence to regulatory requirements, in alignment with the standards set by the National Medical Products Administration.