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

Covidienllc, a medical device manufacturer, initiated a voluntary Class II recall of its arc-shaped staple container for disposable endoscopic cutting staplers (Registration Certificate No.: 20153461467) through its agent, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. The recall was reported to the National Medical Products Administration (NMPA) on September 29, 2017, and published on November 4, 2017. The primary issue prompting the recall was the potential for the staple cartridge to become loose during surgical use. This malfunction could necessitate the removal of detached components or lead to incomplete tissue anastomosis, posing risks to patient outcomes. The problem was identified following two global complaints and attributed to a manufacturing error affecting specific batches, including Batch Number N6L0351X, model EGIARADXT. The product, a laparoscopic disposable cutting and anastomosis device arc-shaped staple cartridge, is designed for various surgical procedures, including general, abdominal, obstetrics and gynecology, thoracic, and deep pelvic surgeries. The recall impacts regions such as Latin America, Europe, and Japan. Despite the identified issue, no patient injuries related to this specific problem have been reported by Medtronic (parent company of Covidien). The company's required action is the voluntary recall of the affected products.