# China NMPA Product Recall - Blood flow diversion embolization device

Source: https://www.keypedia.com/records/china_product_recall/covidien-medical-devices-international-trading-shanghai-co-ltd/ab830034-d194-41e2-a80c-3dad094ea82c
Source feed: China

> China NMPA product recall for Blood flow diversion embolization device by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. published March 26, 2020. Recall level: Level 1 Recall. On March 26, 2020, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a v

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Covidien Medical Devices International Trading (Shanghai) Co., Ltd. is voluntarily recalling its flow diversion embolization devices.
- Company Name: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-03-26
- Product Name: Blood flow diversion embolization device
- Recall Level: Level 1 Recall
- Recall Reason: The product in question has weak welds, thus posing a potential risk of fracture at the distal end during use.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Summary: On March 26, 2020, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class I recall for its flow diverting embolization devices. This critical action was taken after identifying a significant manufacturing defect: weak welding within the products. This flaw presented a substantial safety concern, as it created a potential for the device to break distally during surgical use. Such a malfunction could lead to severe patient complications, highlighting why the recall was classified as Class I – indicating a situation where there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. The recall, indexed as NMPA JGXX-2020-10181 and Shanghai Food and Drug Administration Medical Device Recall 2020-049 (Update 1), fell under the oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. Covidien's required action involved the removal of all affected flow diverting embolization devices, registered under Certificate No.: 20173772468, from the market. Comprehensive details on specific models, specifications, and batch numbers were communicated through an accompanying Medical Device Recall Event Report Form, ensuring all relevant stakeholders were informed to mitigate patient risk effectively.

Company: https://www.keypedia.com/companies/covidien-medical-devices-international-trading-shanghai-co-ltd/4fdf08b9-af8e-4aed-8993-3e905e973d3b