China NMPA Product Recall - Polyp removal device

Cook (China) Medical Trading Co., Ltd. initiated a voluntary Class II recall of its polyp removal device, as reported by the National Medical Products Administration (NMPA) on December 25, 2018. The decision to recall was prompted by customer complaints received by Wilson-Cook Medical, detailing critical malfunctions with the device's snare. Specific issues include the inability to retract the snare into its sheath and instances of snare deformation. These identified defects carry significant patient safety risks, potentially leading to serious complications such as organ perforation or requiring more invasive medical interventions, including the surgical removal of the device. This recall falls under the regulatory oversight of the Shanghai Food and Drug Administration, as indicated by its Medical Device Registration Certificate No. 2018-310. The company is actively working to address these issues, with detailed information concerning the affected product models, specifications, and batches provided in the 'Medical Device Recall Event Report Form.' This measure demonstrates Cook (China)'s commitment to maintaining product safety standards and complying with national medical device regulations.