China NMPA Product Recall - Single-use intravascular imaging catheter (Hybrid Catheter)

Conavi Medical Inc. has initiated a voluntary Class II recall for its single-use intravascular imaging catheters, specifically the Hybrid Catheter (National Medical Device Registration Certificate No. 20233060333). This action, reported by Conavi Medical Technology (Wuhan) Co., Ltd., stems from a critical manufacturing issue: catheter sheath detachment. The recall was publicly announced by the National Medical Products Administration (NMPA) on March 28, 2025. The regulatory framework for this action falls under the NMPA's oversight for medical device safety in China. A significant detail is that the products subject to this recall were not imported into China, thereby mitigating direct impact on the Chinese market. Required actions involve Conavi Medical Inc. managing this voluntary recall, with specific details on affected models, specifications, and batches available in an accompanying "Medical Device Notice" and Recall Event Report Form. This proactive measure highlights the company's commitment to addressing product defects and ensuring patient safety.