China NMPA Product Recall - Disposable external aspiration tubing Riptide™ Large Bore Aspiration Tubing
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Micro Therapeutics, Inc. (DBA ev3 Neurovascular) has initiated a voluntary Class III recall, reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd., for specific batches of its Riptide™ Large Bore Aspiration Tubing. This recall, published by the National Medical Products Administration (NMPA) on November 21, 2025, addresses a labeling discrepancy. The main issue involves product labels displaying incorrect, prematurely early use-by dates on packaging bags and/or cartons, differing from the actual three-year shelf life. Despite receiving five complaints by October 31, 2025, investigations confirmed that the affected products were still within their true shelf life (manufactured October 2024), ensuring no risk to patient safety. Under NMPA regulatory oversight for imported medical devices, the company is taking action to remove the mislabeled batches from circulation. Detailed information regarding affected product models, specifications, and batch numbers is provided in the "Medical Device Recall Event Report Form."
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