# China NMPA Product Recall - Angiography catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-international-medical-trade-shanghai-co-ltd/c95a75e9-cc49-4a55-8ef5-9f717c84d38b/
Source feed: China

> China NMPA product recall for Angiography catheter by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. published February 13, 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 Trading (Shanghai) Co., Ltd. has initiated a voluntary recall of angiography catheters.
- Company Name: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Publication Date: 2020-02-13
- Product Name: Angiography catheter
- Recall Level: Level 2 Recall
- Recall Reason: Some batches of products experienced tip breakage during or before surgery.
- 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 of its angiography catheters, as reported on February 13, 2020, under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. This action was prompted by an increase in complaints concerning the device's integrity. Specifically, the main issue identified was tip breakage in certain batches of angiography catheters, occurring either during surgical procedures or prior to their use. This defect presented a potential risk to patient safety and the effectiveness of medical interventions. The Class II designation indicates that the product issue could lead to temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote. As a required action, Boston Scientific is retrieving the affected units from the market. Comprehensive details, including specific models, specifications, and batch numbers of the recalled products, are available in the accompanying "Medical Device Recall Event Report Form," demonstrating adherence to the NMPA's regulatory framework for ensuring product quality and patient safety.

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