China NMPA Product Recall - Laparoscopic disposable stapler with curved staple cartridge

This document details a voluntary Class II medical device recall initiated by Covidien LLC, a manufacturer under Medtronic. The recall, publicly reported by China's National Medical Products Administration (NMPA) on November 3, 2017, concerns specific batches of its Laparoscopic Disposable Cutting Anastomosis Device with Arc-shaped Staple Container (model EGIARADXT, batch N6L0351X). The primary issue identified is a manufacturing error that could cause the device's staple container to become loose during surgical use. This malfunction poses a risk of requiring the removal of detached components or leading to incomplete tissue anastomosis, potentially compromising surgical outcomes. Two global complaints prompted the recall, although no patient injuries have been reported to date. Operating under the National Medical Device Registration Certificate 20153461467, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. submitted the recall report on September 29, 2017. The voluntary recall affects products distributed in regions such as Latin America, Europe, and Japan. Importantly, the specific batches of affected products were not sold within the Chinese market, meaning no direct corrective actions are required for products in China. The NMPA's publication serves to inform stakeholders about this global recall.