# China NMPA Product Recall - Intra-aortic balloon catheter and accessories

Source: https://www.globalkeysolutions.net/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/681c3af1-7e69-4119-b127-a317b32e0012/
Source feed: China

> China NMPA product recall for Intra-aortic balloon catheter and accessories by Maikewei (Shanghai) Medical Equipment Co., Ltd. published August 07, 2020. Recall level: Level 2 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of its intra-a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maco (Shanghai) Medical Equipment Co., Ltd. is voluntarily recalling intra-aortic balloon catheters and accessories.
- Company Name: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Publication Date: 2020-08-07
- Product Name: Intra-aortic balloon catheter and accessories
- Recall Level: Level 2 Recall
- Recall Reason: Before product sterilization, the manufacturer performs functional testing on a small sample of each batch. These tested products may not meet AAMI ST72 requirements for endotoxin testing. Affected products may pose a significant risk to patients with severe cardiopulmonary disease and weakened immune systems.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Summary: Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall of its intra-aortic balloon catheters and accessories, as reported by the National Medical Products Administration (NMPA) via the Shanghai Municipal Drug Administration on August 7, 2020. The recall pertains to products manufactured between February 3, 2017, and February 21, 2020. The primary issue identified was that functional tests conducted on a small number of samples from each batch, prior to sterilization, indicated that endotoxin levels might not comply with AAMI ST72 requirements. This potential non-compliance presents a significant health risk, particularly for vulnerable patients with severe cardiopulmonary conditions and compromised immune systems. In response to this safety concern, the company is recalling affected intra-aortic balloon catheters and accessories, registered under certificate numbers 20163770667, 20153772355, and 20183771789. The company's action demonstrates a commitment to customer safety and product efficacy. Further specific details regarding models, specifications, and batch numbers are available in the accompanying Medical Device Recall Event Report Form.

Company: https://www.globalkeysolutions.net/companies/maikewei-shanghai-medical-equipment-co-ltd/77310e7c-a692-4918-a052-23f3348af2e9/