# China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

Source: https://www.globalkeysolutions.net/records/china_product_recall/datascope-corp/615e0968-ebf1-431d-b81d-1bc13f1bb3ed/
Source feed: China

> China NMPA product recall for Intra-aortic balloon counterpulsation pump by Datascope Corp published August 09, 2019. Recall level: Level 1 Recall. The National Medical Products Administration (NMPA) announced a Level 1 voluntary recall initiated b

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Datascope Corp. Active Recall of Intra-Aortic Balloon Counterpulsation Pump
- Company Name: Datascope Corp
- Publication Date: 2019-08-09
- Product Name: Intra-aortic balloon counterpulsation pump
- Recall Level: Level 1 Recall
- Recall Reason: The product in question was found to have been improperly maintained with its battery according to the operating instructions. Consequently, when using battery mode, the runtime provided may be less than the battery's minimum expected runtime.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Datascope Corp
- Summary: The National Medical Products Administration (NMPA) announced a Level 1 voluntary recall initiated by Datascope Corp. for its Intra-Aortic Balloon Counterpulsation Pumps, with the recall details published on August 9, 2019. The issue, reported by Maikewei (Shanghai) Medical Equipment Co., Ltd., stems from a critical flaw where battery maintenance was not performed according to the product's instructions. This oversight could lead to the device's battery operating for a duration less than its minimum expected life when running on battery power. Datascope Corp. is proactively recalling affected units, classified as Level 1 by the NMPA, indicating a serious health hazard. This recall highlights the NMPA's rigorous regulatory framework, which mandates prompt action from manufacturers to address and rectify product deficiencies to ensure patient safety and product reliability.

Company: https://www.globalkeysolutions.net/companies/datascope-corp/142b819e-10e1-4fd4-ad34-3e11deb1f442/