# China NMPA Product Recall - Intra-Aortic Balloon Pump (trade name: CARDIOSAVE)

Source: https://www.globalkeysolutions.net/records/china_product_recall/maikewei-shanghai-medical-equipment-co-ltd/caca5acf-586e-4d3d-87c5-ca93903ac0c9/
Source feed: China

> China NMPA product recall for Intra-Aortic Balloon Pump (trade name: CARDIOSAVE) by Maikewei (Shanghai) Medical Equipment Co., Ltd. published March 30, 2021. Recall level: Level 3 Recall. Maikewei (Shanghai) Medical Equipment Co., Ltd. initiated a voluntary Class 3 recall for its Intra-A

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maco (Shanghai) Medical Equipment Co., Ltd. is voluntarily recalling its Intra-Aortic Balloon Pump (trade name: CARDIOSAVE).
- Company Name: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Publication Date: 2021-03-30
- Product Name: Intra-Aortic Balloon Pump (trade name: CARDIOSAVE)
- Recall Level: Level 3 Recall
- Recall Reason: A network security vulnerability in Ripple20 could cause device network communication disruptions.
- 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 3 recall for its Intra-Aortic Balloon Pumps, marketed as CARDIOSAVE. This action was reported on March 30, 2021, and falls under the regulatory oversight of the National Medical Products Administration (NMPA) and the Shanghai Municipal Drug Administration. The recall addresses a potential network communication interruption issue stemming from a known cybersecurity vulnerability, Ripple20. While the company confirmed that the pump's performance and patient treatment remain unaffected, and no adverse events have been reported related to this vulnerability, the proactive measure was taken. The affected devices carry CFDA Import Medical Device Registration Numbers 20143214542 and 20193082223. To facilitate the recall, Maikewei (Shanghai) Medical Equipment Co., Ltd. has provided a "Medical Device Recall Event Report Form" with detailed information on specific affected product models, specifications, and batch numbers.

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