# 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/1f8d0cb3-d606-474e-ae28-63c3d3d46a32/
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 03, 2019. Recall level: Level 2 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class II recall on July 3, 201

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maco (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: 2019-07-03
- Product Name: Intra-aortic balloon counterpulsation pump (brand name: CARDIOSAVE)
- Recall Level: Level 2 Recall
- Recall Reason: Because different IABP models have varying battery runtimes and discharge cycles, manufacturers proactively inform customers to ensure all IABP users follow the recommendations in the equipment's operating instructions regarding battery use, charging, maintenance, and storage. 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 when using battery 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 II recall on July 3, 2019, for its Intra-Aortic Balloon Counterpulsation Pump (IABP), specifically models branded "CARDIOSAVE." The core issue stems from variations in battery runtime and discharge cycles across different IABP models. The company identified that if users do not strictly follow the battery usage, charging, maintenance, and storage guidelines outlined in the device’s operating instructions, the IABP may provide less than the expected minimum runtime when operating on battery power. This proactive measure falls under the regulatory purview of the National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration. As part of this recall, Maikewei is proactively instructing all IABP users to meticulously adhere to the recommendations provided in the device’s operating instructions regarding battery management. This action is crucial to ensure consistent and safe device performance. Further comprehensive details concerning the specific affected product 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/