China NMPA Product Recall - Double balloon three-lumen catheter

Wuxi Huaan Medical Device Co., Ltd. initiated a voluntary Class III recall of its Double-Balloon Three-Lumen Catheter, as announced by the National Medical Products Administration (NMPA) on January 30, 2019. This action was prompted by multiple adverse event reports from Zhongshan People's Hospital, detailing instances of balloon rupture during the product's use. The primary issue identified is the potential for the device's balloon component to fail, posing a risk of harm to patients. The recall affects specific batches of the catheter, identified by production batch numbers including 20170805, 20171005, 20180105, and 20180505, impacting a total of 408 units across various production dates. These devices are intended for gastric fundus and esophageal compression hemostasis. Under the NMPA's regulatory oversight, the company's required actions involve contacting all regional distributors to verify existing inventory and mandating the return of all remaining stock of the affected product. This measure aims to mitigate potential patient harm by removing the faulty catheters from circulation. The recall underscores the importance of post-market surveillance and manufacturer responsibility in addressing device safety concerns.