China NMPA Product Recall - Trevo microcatheter

Stryker Neurovascular, supported by its affiliate Stryker (Beijing) Medical Devices Co., Ltd., has initiated a voluntary Class III recall for specific batches of its Trevo microcatheters. This action, reported to the National Medical Products Administration (NMPA) on December 20, 2023, addresses an administrative oversight where certain configured microcatheters were incorrectly distributed to customers within the United States. The affected products are identified under National Medical Device Registration Certificates 20153033916 and 20223030396. Detailed information regarding the precise models, specifications, and batch numbers is available in the "Medical Device Recall Event Report Form" issued by the company. It is crucial to note that this specific recall does not impact the Chinese market. The primary issue involved a shipment error, not a product defect. While no inspection dates were provided within the document, the required action is the immediate and comprehensive recall of all identified incorrect shipments to uphold product distribution integrity and regulatory compliance in the affected regions.