China NMPA Product Recall - NanoCross Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheter

The National Medical Products Administration (NMPA) issued a notice on June 4, 2025, concerning a voluntary Class II recall initiated by Medtronic, Inc. This action follows an increase in complaints about deflation difficulties observed in their NanoCross Elite 0.014" Over-the-Wire PTA Balloon Dilatation Catheters, specifically impacting 5mm and 6mm balloon sizes. The issue, reported by Covidien Medical Devices International Trading (Shanghai) Co., Ltd., pertains to products manufactured in China, registered under National Medical Device Registration Certificate No. 20193030436. The primary concern is the catheter's inability to deflate as intended, which could compromise patient safety during peripheral angioplasty procedures. Medtronic, Inc. is undertaking this recall to address the performance issue and uphold product reliability. Manufacturers are mandated to ensure their devices meet safety and performance standards post-market. Detailed information regarding the specific models, specifications, and affected batches is accessible in the accompanying 'Medical Device Recall Event Report Form.' This regulatory action emphasizes the NMPA's role in monitoring medical device quality and manufacturers' responsibility in responding to reported product deficiencies to protect public health.