# China NMPA Product Recall - Coronary balloon dilation catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/5ebf3651-5c23-4511-9b69-a70a4a51b78e/
Source feed: China

> China NMPA product recall for Coronary balloon dilation catheter by Abbott Trading (Shanghai) Co., Ltd. published February 25, 2020. Recall level: Level 1. Abbott Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class I recall of its coro

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Abbott Medical Devices Trading (Shanghai) Co., Ltd. is voluntarily recalling its coronary balloon dilation catheters.
- Company Name: Abbott Trading (Shanghai) Co., Ltd.
- Publication Date: 2020-02-25
- Product Name: Coronary balloon dilation catheter
- Recall Level: Level 1
- Recall Reason: Excessive heat exposure during manufacturing weakens the proximal material at the balloon connection point, which may lead to problems such as difficulty in balloon retraction or inability to retract the balloon. Furthermore, deaths related to this product have been identified overseas.
- Discovering Company: Abbott Medical Devices Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Abbott Trading (Shanghai) Co., Ltd.
- Summary: Abbott Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class I recall of its coronary artery balloon dilation catheters, as announced by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration (SFDA) on February 25, 2020. The recall, identified as number 2020-032, was prompted by a critical manufacturing defect: excessive heat exposure during production. This exposure could lead to the balloon becoming difficult or impossible to retract, posing significant patient safety risks. The decision to upgrade the recall to a Level 1 classification was made in response to reported deaths associated with the product overseas. This highest level of recall indicates 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. Abbott Medical Devices Trading (Shanghai) Co., Ltd. was required to implement this recall and provide detailed information regarding affected models, specifications, and batches in a Medical Device Recall Event Report Form. The regulatory bodies oversaw this critical action to mitigate potential harm to patients. This event highlights the stringent oversight by the NMPA and SFDA to ensure the safety and efficacy of medical devices within their jurisdiction.

Company: https://www.globalkeysolutions.net/companies/abbott-trading-shanghai-co-ltd/851d8fbf-2dac-497e-bf33-820114081013/