China NMPA Product Recall - microcatheter

The National Medical Products Administration (NMPA) announced a voluntary Class III recall concerning microcatheters manufactured by Micro Therapeutics, Inc. DBA ev3 Neurovascular. This recall, published on February 5, 2024, was reported in China by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. The primary reason for the recall is the introduction of these medical devices into the U.S. market with instructions for use that did not comply with those approved by the U.S. Food and Drug Administration (FDA). This non-compliance led to the manufacturer initiating the recall. A Class III recall indicates that the use of or exposure to the affected product is not likely to cause adverse health consequences. The specific models, specifications, and batch numbers of the microcatheters subject to this recall are detailed in an accompanying Medical Device Recall Event Report Form. This action highlights the critical importance of adhering to country-specific regulatory approvals and instructions for use to ensure product integrity and patient safety globally.