# China NMPA Product Recall - Wingspan support system

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/e8636cd1-af09-4d59-8035-228f8c958830/
Source feed: China

> China NMPA product recall for Wingspan support system by Boston Scientific Corporation published November 03, 2010. Recall level: . Boston Scientific, Inc. and its Chinese subsidiary, Boston Scientific International Medical Trading 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Event Report Form for Stent Systems
- Company Name: Boston Scientific Corporation
- Publication Date: 2010-11-03
- Product Name: Wingspan support system
- Recall Reason: In internal testing, Boston Scientific found that two batches of the product had radial support slightly below the product standard. While the slight decrease in support is unlikely to increase the risk of any patient injury, if the affected stent is used in a stenotic lesion of atherosclerosis, revascularization or the use of other devices may be required, leading to delays in clinical procedures. Theoretically, this also presents a small possibility of plaque detachment, transient ischemic attack, or stroke.
- Discovering Company: Boston Scientific
- Manufacturing Company: Boston Scientific Corporation
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/29488af7-a1d7-4d3b-a8ab-1f12fddb5e4b/