China NMPA Product Recall - External drainage and monitoring system

Medtronic Inc. initiated a voluntary Class I recall of its external drainage and monitoring systems (National Medical Device Registration Certificates 20163145109 and 20163665109). The recall, reported by Medtronic (Shanghai) Management Co., Ltd. on December 31, 2024, was prompted by concerns regarding the potential for cracks or leaks in the three-way valve. This issue is attributed to over-tightening during use, which could lead to serious patient infections. The National Medical Products Administration (NMPA) published this recall, highlighting its significance due to the high risk involved, classified as Class I. Affected product models, specifications, and batches are detailed in the accompanying "Medical Device Recall Event Report Form". The company is taking proactive steps to address this critical safety concern in compliance with NMPA regulations to ensure patient safety and product integrity. This recall underscores the importance of stringent quality control and user awareness regarding medical device handling.