China NMPA Product Recall - Wingspan support system

Boston Scientific, Inc. and its Chinese subsidiary, Boston Scientific International Medical Trading (Shanghai) Co., Ltd., initiated a recall for specific batches of their Wingspan Stent System. This action, documented by the National Medical Products Administration (NMPA) in November 2010 under the Medical Device Recall Event Report Form (NMPA Medical Device (Imported) No. 2006 Stent System), followed internal testing that revealed two product batches had radial support slightly below their established standards. Radial support is critical for maintaining the stent's position and ensuring vessel patency after implantation. While Boston Scientific reported no patient injuries or complaints related to this issue, a theoretical risk was identified. If affected stents were used in stenotic atherosclerotic lesions, there was a small possibility of clinical procedure delays, the need for additional revascularization, or even rare occurrences of plaque dislodgement, transient ischemic attack (TIA), or stroke. In response, Boston Scientific initiated a recall, identified and notified all 19 affected customers in regions including China, Denmark, and Italy. The company implemented a plan to notify customers via mail, fax, and visits. Although the original plan mentioned product returns, the completion status indicated that no affected products needed to be returned from customers. The recall action was officially closed on September 9, 2010.