China NMPA Product Recall - Venous sheath

Edwards Lifesciences LLC, in conjunction with its agent Edwards (Shanghai) Medical Supplies Co., Ltd., executed a voluntary Class III recall of its Vein Vascular Sheath, specifically model 1355BF9. This action, reported to the National Medical Products Administration (NMPA) and published on May 7, 2019, addresses a manufacturing anomaly within the medical device. The core issue involves the nylon disk inside the venous sheath, which was found to have a non-compliant size. This dimensional discrepancy poses a potential challenge during clinical use, as healthcare professionals may encounter difficulty inserting the dilator into the vascular sheath. While this defect is not expected to cause product leakage or severe patient harm, it could necessitate device replacement during a procedure, leading to unforeseen delays for patients and medical staff. The recall, impacting regions including Europe, the Middle East, and Asia Pacific, was initiated to mitigate this functional impairment. The regulatory framework under which this recall operates is the NMPA's medical device oversight, given the product's registration under National Medical Device Registration Certificate 20163772634. The required action by the company is to remove the affected batches from distribution.