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

Source: https://www.globalkeysolutions.net/records/china_product_recall/datascope-corp/40a9f579-5a4f-43b3-9fcc-a8c3a34bda91/
Source feed: China

> China NMPA product recall for Intra-aortic balloon counterpulsation pump by Datascope Corp published February 24, 2023. Recall level: Level 1 Recall. Datascope Corp., the manufacturer of intra-aortic balloon counterpulsation pumps, has initiated a vo

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Datascope Corp., a medical company, is actively recalling its intraaortic balloon pump.
- Company Name: Datascope Corp
- Publication Date: 2023-02-24
- Product Name: Intra-aortic balloon counterpulsation pump
- Recall Level: Level 1 Recall
- Recall Reason: There is an issue with unexpected downtime.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Datascope Corp
- Summary: Datascope Corp., the manufacturer of intra-aortic balloon counterpulsation pumps, has initiated a voluntary Class I recall of specific models and batches of its product. This action was reported by Maikewei (Shanghai) Medical Equipment Co., Ltd. on February 24, 2023. The primary reason for the recall is the occurrence of unexpected downtime issues affecting the functionality of these critical medical devices. A Class I recall signifies that there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. The recall involves products with registration certificates CFDA (Imported) 2014 No. 3214542 and CFDA Import Registration No. 20193082223. This regulatory action is overseen by the National Medical Products Administration (NMPA). Affected parties are directed to refer to the "Recall Event Report Form" and its attachment for detailed information on the specific product models, specifications, and batch numbers impacted by this recall. The immediate required action is the removal of these potentially faulty devices from the market to ensure patient safety.

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