China NMPA Product Recall - Angioguard RX Emboli Capture Guidewire System

The National Medical Products Administration (NMPA) issued an alert on March 27, 2023, regarding a voluntary Class I recall by Cordis Corporation. This significant action addresses a critical safety concern with the Angioguard RX Emboli Capture Guidewire System, registered under Certificate No. 20153032577. Cordis (Shanghai) Medical Devices Co., Ltd. reported the primary issue: a potential for separation between the release sheath and the recovery sheath in units manufactured after a specific, undisclosed date. The Class I designation signifies that use of the affected product could foreseeably cause serious injury or death. Under the NMPA's regulatory framework, Cordis Corporation, as the manufacturer, is initiating this recall to mitigate potential harm to patients. The required action involves the company retrieving all identified faulty devices from the market. Comprehensive details, including specific affected product models, specifications, and batch numbers, are provided in the accompanying "Medical Device Report Form." This recall underscores a proactive measure to ensure patient safety and compliance with medical device standards.