China NMPA Product Recall - Disposable sphincterotomy knife

The National Medical Products Administration (NMPA) issued a report on June 27, 2024, detailing a voluntary Class II recall initiated by Boston Scientific Corporation for its single-use Cannulating Sphincterotome (National Medical Device Registration Certificate No. 20173010673). This recall was formally reported by Boston Scientific International Medical Trading (Shanghai) Co., Ltd. The notice does not pertain to inspection dates but rather a voluntary recall event.The primary issue prompting this recall involves the detection of foreign objects within the sealed section of the cutting wire, specifically located between the device's handle and its distal end. This manufacturing defect presents a potential risk to the product's intended function and could compromise patient safety during use.Under the NMPA's regulatory framework, a Class II recall signifies a situation where the use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.As a required action, Boston Scientific Corporation has undertaken the voluntary recall of the affected product. An important detail is that the specific models involved in this recall were confirmed not to have been imported into China, thereby mitigating any direct impact on the Chinese medical device market. Further comprehensive details regarding specific models are available in the attached Medical Device Recall Event Report Form.