# China NMPA Product Recall - Hurricane RX Biliary Balloon Dilatation Catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-international-medical-trade-shanghai-co-ltd/e2016059-80aa-4c54-bdda-a17d534b04bd/
Source feed: China

> China NMPA product recall for Hurricane RX Biliary Balloon Dilatation Catheter by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. published September 17, 2020. Recall level: Level 2 Recall. Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class II 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific International Medical Trade (Shanghai) Co., Ltd. is voluntarily recalling its rapid exchange biliary balloon dilation catheter.
- Company Name: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Publication Date: 2020-09-17
- Product Name: Hurricane RX Biliary Balloon Dilatation Catheter
- Recall Level: Level 2 Recall
- Recall Reason: Complaints about the black cannula detaching from the catheter shaft have increased in certain batches of rapid exchange biliary balloon dilation catheters.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Summary: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall for a specific batch of its Hurricane RX Biliary Balloon Dilatation Catheter. This significant action, publicly reported on September 17, 2020, through the National Medical Products Administration (NMPA), was undertaken in response to an increase in customer complaints. The core issue driving this recall is the detachment of the black cannula from the catheter stem of the affected devices. The company's decision to conduct this recall, affecting products under Registration Certificate No. 20173770178, highlights its proactive approach to product safety and quality assurance. While an elevated number of complaints regarding the product's structural integrity have been received, Boston Scientific confirms that no patient injuries have been reported in connection with this specific cannula detachment issue. The regulatory framework overseeing this process is the NMPA, to which the company reported the voluntary recall. Consumers and healthcare providers requiring further details on the exact models, specifications, and batch numbers impacted by this recall are directed to consult the comprehensive "Medical Device Recall Event Report Form" provided by the company. This swift and voluntary action underscores Boston Scientific's adherence to medical device safety standards and its commitment to public health.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-international-medical-trade-shanghai-co-ltd/bc370948-4fe0-497a-93dd-bbac3a59dd56/