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

Source: https://www.globalkeysolutions.net/records/china_product_recall/datascope-corp/d4a3de12-989e-43c5-804e-02b60b0ad563/
Source feed: China

> China NMPA product recall for Intra-aortic balloon counterpulsation pump by Datascope Corp published May 16, 2014. Recall level: . Datascope Corp., through its distributor MAQUET (Shanghai) Medical Equipment Co., Ltd., initiated a 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Datascope Corp. of the United States is recalling its intraaortic balloon counterpulsation pump.
- Company Name: Datascope Corp
- Publication Date: 2014-05-16
- Product Name: Intra-aortic balloon counterpulsation pump
- Recall Reason: A malfunctioning cooling fan may cause the power module to overheat, leading to the shutdown of the intra-aortic balloon pump.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Datascope Corp
- Summary: Datascope Corp., through its distributor MAQUET (Shanghai) Medical Equipment Co., Ltd., initiated a voluntary global recall of its Intra-Aortic Balloon Counterpulsation Pump (CFDA (Imported) No. 2010321333). This recall, publicly announced by the National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Administration on May 16, 2014, addresses a critical product defect. The primary issue identified is a potential malfunction of the device's cooling fan, which can lead to the power module overheating and subsequently cause the pump to shut down unexpectedly. This malfunction was assessed as presenting a 'Medium Risk' to patient safety. The affected product model is CS100, with 308 units sold and imported into China. Under the regulatory oversight of the NMPA, MAQUET (Shanghai) Medical Equipment Co., Ltd. promptly implemented corrective actions. These included issuing a "Medical Device Recall Notice" to all affected customers and initiating inspections of the cooling fans on the power modules of the recalled pumps, with replacements performed as needed. Furthermore, regulatory bodies at provincial, autonomous region, and municipal levels were directed to enhance their supervision and management of similar medical devices to ensure public health and safety.

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