# China NMPA Product Recall - Angiographic Catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/4679b1d2-5f3c-49b4-8483-94b94674f770/
Source feed: China

> China NMPA product recall for Angiographic Catheter by Boston Scientific Corporation published August 17, 2020. Recall level: Level 1. Boston Scientific Corporation initiated a voluntary Class I recall of its Angiographic Catheter prod

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific Corporation voluntarily recalls its Angiographic Catheter.
- Company Name: Boston Scientific Corporation
- Publication Date: 2020-08-17
- Product Name: Angiographic Catheter
- Recall Level: Level 1
- Recall Reason: The company discovered through complaints that the tip of certain batches of products might have become brittle due to external factors, causing the tip to detach during or before surgery, leading to problems.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: Boston Scientific Corporation initiated a voluntary Class I recall of its Angiographic Catheter product, as reported by the National Medical Products Administration (NMPA) on August 17, 2020. The recall was prompted by customer complaints indicating that the tip of certain product batches could become brittle due to external factors. This brittleness poses a significant risk, as it may lead to the detachment of the catheter tip either during surgical procedures or prior to use. The potential for tip detachment could result in serious adverse health consequences for patients, warranting the highest level of recall. Boston Scientific International Medical Trade (Shanghai) Co., Ltd. communicated this serious product defect, leading to the manufacturer's decision to remove the affected devices from the market. The specific details regarding the recalled product's registration certificate, model, specifications, and batch numbers are available in the accompanying "Medical Device Recall Event Report Form." This action underscores the company's commitment to patient safety and adherence to NMPA regulations concerning medical device quality and performance.

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