# China NMPA Product Recall - Coronary balloon dilation catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/abbott-trading-shanghai-co-ltd/ecfc4034-4390-41ed-9ae6-f1c73a117f0a/
Source feed: China

> China NMPA product recall for Coronary balloon dilation catheter by Abbott Trading (Shanghai) Co., Ltd. published January 27, 2020. Recall level: Level 3 Recall. Abbott Medical Devices Trading (Shanghai) Co., Ltd. initiated a voluntary Class III recall of its co

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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: 2020-01-27
- Product Name: Coronary balloon dilation catheter
- Recall Level: Level 3 Recall
- Recall Reason: Excessive heat exposure during manufacturing can weaken the material near the balloon connection, potentially leading to difficulties or even failure to retract the balloon.
- 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 III recall of its coronary artery balloon dilatation catheters (Registration Certificate Nos.: 20153772385; 20173771561) on January 27, 2020. This action, reported by the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration, addresses a critical manufacturing defect. The primary concern is the weakening of the proximal material at the balloon connection point, attributed to excessive heat exposure during the production process. This defect poses a risk of difficulties or complete inability to retract the balloon, which could compromise patient safety during medical procedures. Specific details regarding affected product models, specifications, and batch numbers are contained in an associated "Medical Device Recall Event Report Form." The regulatory framework governing this recall falls under the NMPA, overseeing medical device safety. While specific inspection dates leading to this recall are not detailed in the provided document, the company's required action is to conduct this voluntary recall to mitigate the identified product defect, ensuring the removal of affected products from circulation and protecting public health.

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