China NMPA Product Recall - PTA catheter

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall for specific PTA Catheters in China, formally reported to the National Medical Products Administration (NMPA) on October 23, 2015, and publicly announced on November 18, 2015. The decision stemmed from standard internal packaging testing by Medtronic, which identified a potential vulnerability where the sterility of the PTA catheter packaging bags could be compromised under extreme use conditions. The affected products, manufactured by Invatec S.p.A., include multiple models and batches (e.g., 209759618, 209532768, etc.). The company confirmed that, as of October 15, 2015, no customer complaints or adverse event reports related to packaging seal integrity breaches had been received. Operating under the NMPA's regulatory oversight for medical devices, specifically referencing the CFDA (Imported) No. 20133773936, Medtronic has outlined clear corrective actions. These include promptly dispatching notification letters to inform relevant stakeholders and actively recalling all unused affected products from the market. Subsequently, these recalled PTA catheters are to be returned to the original manufacturer. This proactive recall demonstrates the company's commitment to patient safety and adherence to strict medical device quality and sterility standards within the Chinese regulatory framework.