China NMPA Product Recall - Endoscopic Vessel Harvesting System

MAQUET Cardiovascular LLC has initiated a voluntary Class II recall for its Endoscopic Vessel Harvesting System, as documented by the National Medical Products Administration (NMPA) on April 3, 2025. This action addresses several critical product deficiencies that could impact device performance and patient safety. Identified issues include a bent or detached heating wire, compromised silicone adhesion at the acquisition tool's interlocking joint, and the use of an incorrect resistor within the power supply assembly.

The recall, published through MAQUET (Shanghai) Medical Equipment Co., Ltd., specifically concerns products that were not imported into the Chinese market. This indicates a proactive measure by MAQUET Cardiovascular LLC to address potential quality and safety concerns globally, aligning with international medical device vigilance standards. The detailed report, including specific models and batch information, is available in the "Medical Device Recall Event Report Form." This recall underscores the importance of stringent quality control and the prompt addressing of manufacturing or design flaws to maintain product integrity and ensure patient well-being. The Class II classification suggests a situation where the use of a affected product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.