# China NMPA Product Recall - Flexima Biliary Stent (Integrated Biliary Stent)

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/c628211e-3498-43ae-bd79-2fee439a84e7/
Source feed: China

> China NMPA product recall for Flexima Biliary Stent (Integrated Biliary Stent) by Boston Scientific Corporation published May 18, 2010. Recall level: . Boston Scientific Corporation initiated a global recall of its Flexima Biliary Stent system, as repo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Recall Report Form for Flexima Biliary Stent (Trade Name: Flexima)
- Company Name: Boston Scientific Corporation
- Publication Date: 2010-05-18
- Product Name: Flexima Biliary Stent (Integrated Biliary Stent)
- Recall Reason: Boston Scientific is conducting a recall of its Flexima® biliary stent system. Internal inspections revealed a potential sealing defect in the sterile packaging of the affected products. A crack in the sterile packaging could render the device non-sterile. Boston Scientific has not yet reported any patient complications arising from this.
- Discovering Company: Boston Scientific
- Manufacturing Company: Boston Scientific Corporation
- Summary: Boston Scientific Corporation initiated a global recall of its Flexima Biliary Stent system, as reported by the National Medical Products Administration (NMPA) on May 18, 2010. The recall, managed in China by Boston Scientific International Medical Trade (Shanghai) Co., Ltd., stemmed from an internal company inspection revealing a potential sealing defect in the sterile packaging. This defect could compromise the device's sterility, posing a health risk. While no patient complications had been reported, the company recognized the severity of the issue, particularly given the product's use in critical procedures like bile duct drainage. Under the NMPA's regulatory oversight, Boston Scientific implemented a comprehensive recall plan. This involved identifying all affected customers based on shipping records, issuing formal notifications through various channels, and arranging for the return of the compromised stents. The company aimed to complete these corrective actions by July 26, 2010, ensuring the removal of potentially non-sterile products from circulation across multiple affected regions, including China.

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