China NMPA Product Recall - Anterograde perfusion cannulation Cardioplegia Delivery Cannula

Medtronic Inc., through its affiliate Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class I recall for its Cardioplegia Delivery Cannula. This action was officially reported to the National Medical Products Administration (NMPA) on April 17, 2025. The recall is prompted by the discovery of suspected scratches and loose plastic material within the male Luer connector of the anterograde perfusion cannulas. This quality issue poses a potential risk, necessitating the highest level of recall classification. The affected product is identified by National Medical Device Registration Certificate No. 20153101305. Medtronic is taking immediate steps to address this concern, working within the NMPA's regulatory framework for medical device safety. Comprehensive information, including specific models, specifications, and batch numbers of the impacted devices, is detailed in the accompanying "Medical Device Recall List" and the "Medical Device Recall Event Report Form" provided by the company. This proactive recall demonstrates Medtronic's commitment to ensuring product integrity and public safety by removing potentially compromised medical devices from circulation under regulatory oversight.