China NMPA Product Recall - Disposable sphincterotomy knife

On December 17, 2021, Boston Scientific International Medical Trade (Shanghai) Co., Ltd., also known as Boston Scientific (BSC), announced a voluntary Class III recall affecting specific batches of its disposable sphincterotomy knives. This action followed an internal investigation which revealed that the inner packaging of these critical medical devices could be compromised, thereby jeopardizing the product's sterility barrier. The primary concern associated with a breach in sterility is the potential for infection in patients. Specifically, the use of a non-sterile sphincterotomy knife poses a risk of postoperative bile duct infection, a condition that typically requires medical evaluation and treatment with oral or intravenous antibiotics. Although Boston Scientific has not received any reports of patient-related adverse events directly linked to this issue, the company initiated the recall as a precautionary measure to uphold patient safety standards. The National Medical Products Administration (NMPA) oversees this regulatory action. Further specific details, including the affected product models, specifications, and batch numbers, are fully documented in the "Medical Device Recall Event Report Form" provided by the company. This recall underscores the commitment to ensuring the integrity and safety of medical devices used in patient care.