# China NMPA Product Recall - Intra-aortic balloon counterpulsation pump (brand name: CARDIOSAVE)

Source: https://www.globalkeysolutions.net/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/e804e013-4ba9-4b8a-b383-fd8eaa3e3d72/
Source feed: China

> China NMPA product recall for Intra-aortic balloon counterpulsation pump (brand name: CARDIOSAVE) by Maikewei (Shanghai) Medical Equipment Co., Ltd. published July 29, 2019. Recall level: Level 1 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class I recall, updated on Jul

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Macowell (Shanghai) Medical Equipment Co., Ltd. is voluntarily recalling its intra-aortic balloon counterpulsation pump (IACP), including the IACP and its product (trade name: CARDIOSAVE).
- Company Name: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Publication Date: 2019-07-29
- Product Name: Intra-aortic balloon counterpulsation pump (brand name: CARDIOSAVE)
- Recall Level: Level 1 Recall
- Recall Reason: Different IABP models have varying battery runtime and discharge cycles. If battery maintenance is not performed according to the IABP's operating instructions, the IABP may provide less runtime than the battery's minimum expected runtime in battery-powered mode.
- 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 I recall, updated on July 29, 2019, for its Intra-Aortic Balloon Counterpulsation Pump (CARDIOSAVE) due to a critical battery performance issue. This action, overseen by the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration, addresses inconsistencies in battery runtime and discharge cycles across various IABP models. The primary concern is that if users do not strictly follow the operating instructions for battery use, charging, maintenance, and storage, the device may provide less runtime than expected when operating on battery power. This could pose a significant safety risk in clinical environments. As a required action, the company is proactively informing all customers to adhere meticulously to the battery maintenance recommendations outlined in the device's operating instructions. The recall impacts specific product models, specifications, and batches, underscoring the manufacturer's commitment to patient safety and device reliability.

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