# 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/12ab9604-cba6-4f5e-a3a4-f61a513be2cb/
Source feed: China

> China NMPA product recall for Blood flow diversion embolization device by Covidien Medical Devices International Trading (Shanghai) Co., Ltd. published August 10, 2021. Recall level: Level 2 Recall. On August 10, 2021, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a 

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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: 2021-08-10
- Product Name: Blood flow diversion embolization device
- Recall Level: Level 2 Recall
- Recall Reason: During use, the remote push wire of the Pipeline Flex conveyor system broke. The problem was caused by a defect in the spiral cutting area of the hyaluronic acid tube due to a defect in the raw materials of a specific batch, which may lead to equipment failure and adverse events.
- Discovering Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Covidien Medical Devices International Trading (Shanghai) Co., Ltd.
- Summary: On August 10, 2021, Covidien Medical Devices International Trading (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its flow diverting embolization devices. This action was taken in response to reports of fractured distal push wires within the Pipeline Flex delivery system during use. Investigations revealed a defect in raw materials from a specific manufacturing batch, causing fractures in the helical cut area of the hypo tube. This critical issue can lead to device malfunction and potentially result in adverse events for patients. The recall was reported through the Shanghai Municipal Drug Administration Website and overseen by the National Medical Products Administration (NMPA) as part of its regulatory framework for medical devices. Covidien Medical Devices International Trading (Shanghai) Co., Ltd. is actively recalling the affected products to ensure patient safety and compliance with medical device regulations. Detailed information regarding the specific models, specifications, and batches is available in the associated "Medical Device Recall Event Report Form."

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