China NMPA Product Recall - Affinity NT Oxygenator with Balance Biosurface & Uncoated Cardiotomy/Venous Reservoir (Disposable Membrane Oxygenator)

Medtronic, Inc., in collaboration with Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class I recall for its Single-Use Membrane Oxygenator Affinity NT Oxygenator with Balance Biosurface & Uncoated Cardiotomy/Venous Reservoir. This significant regulatory action, announced by the National Medical Products Administration (NMPA) on October 22, 2025, follows internal testing by Medtronic headquarters. The primary issue identified was a reduced carbon dioxide (CO2) gas transport rate within the 'Spiderman fiber' component, which is manufactured at the Medtronic Danfoss plant. A Class I recall indicates that there is a reasonable probability that the use of, or exposure to, the affected product could cause serious adverse health consequences or death. As a required action under NMPA's regulatory framework, Medtronic is actively recalling all affected product models, specifications, and batch numbers. Detailed information regarding these specific units is provided in the associated "Medical Device Recall Event Report Form." This recall underscores Medtronic's commitment to patient safety and compliance with global medical device standards.