China NMPA Product Recall - Anterograde perfusion cannulation Cardioplegia Delivery Cannula

The National Medical Products Administration (NMPA) has issued an announcement regarding a supplemental Class I recall initiated by Medtronic Inc., reported by Medtronic (Shanghai) Management Co., Ltd. This recall, indexed as JGXX-2025-10099 and publicized on July 31, 2025, addresses significant quality issues identified with the Cardioplegia Delivery Cannula, registered under National Medical Device Registration Certificate No. 20153101305. The primary concern revolves around suspected scratches and the presence of loose plastic material within the male Luer connector used for anterograde irrigation cannulas. These defects are considered critical, necessitating a Class I recall due to the potential for serious adverse health consequences. The initial recall information was released on April 17, 2025, with this document providing an updated notification. Under the NMPA's regulatory framework, Medtronic is obligated to execute this supplemental recall to ensure the removal of all affected products from distribution. Compliance with NMPA's stringent quality and safety standards is mandatory for medical device manufacturers operating within China. Comprehensive details, including the specific types and batch numbers of the impacted devices, are documented in the accompanying "Medical Device Recall Event Report Form," emphasizing the NMPA's dedication to safeguarding public health through rigorous product oversight and corrective actions.