# China NMPA Product Recall - Blood flow diversion embolization device

Source: https://www.globalkeysolutions.net/records/china_product_recall/covidien-medical-devices-international-trading-shanghai-co-ltd/57331c1e-c5cc-4609-84ad-b1cb7c1e31ad/
Source feed: China

> China NMPA product recall for Blood flow diversion embolization device by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. published September 23, 2020. Recall level: Level 2. Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II r

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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: 2020-09-23
- Product Name: Blood flow diversion embolization device
- Recall Level: Level 2
- Recall Reason: Because of past reports of intraoperative breakage and dissociation of the Pipeline Flex flow-directing embolization device, Covidien will update the product information leaflet to further clarify the possibility of device breakage or dissociation due to tortuous vessels and/or excessive resistance, and the potential patient harm it may cause.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Summary: Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its Flex flow diverter embolization devices on September 23, 2020. This action was prompted by reports of intraoperative breakage and dissociation of the device, which could lead to potential patient injury, particularly when used in tortuous vessels or encountering excessive resistance. The company is taking two primary actions: recalling affected devices (Registration Certificate No.: 20173772468) and updating the product information leaflet. The updated leaflet will clearly communicate the possibility of device breakage or dissociation and the associated patient risks under specific conditions. This recall is overseen by the National Medical Products Administration (NMPA) in China, demonstrating the regulatory body's role in ensuring medical device safety and the company's commitment to product transparency and patient well-being.

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