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

Source: https://www.globalkeysolutions.net/records/china_product_recall/datascope-corp/66fdab1d-c3d8-4fd4-a2b4-c822d3238060/
Source feed: China

> China NMPA product recall for Intra-aortic balloon counterpulsation pump by Datascope Corp published January 13, 2017. Recall level: Level III. Maikewei (Shanghai) Medical Equipment Co., Ltd., the responsible unit in China for MAQUET GETINGE GR

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maco (Shanghai) Medical Equipment Co., Ltd. is voluntarily recalling its intraaortic balloon counterpulsation pump.
- Company Name: Datascope Corp
- Publication Date: 2017-01-13
- Product Name: Intra-aortic balloon counterpulsation pump
- Recall Level: Level III
- Recall Reason: Maquet discovered during its ongoing monitoring of the performance of the CARDIOSAVE intra-aortic balloon pump that if the lithium battery is accidentally dropped, it may emit smoke, odor, and sparks.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: Datascope Corp
- Summary: Maikewei (Shanghai) Medical Equipment Co., Ltd., the responsible unit in China for MAQUET GETINGE GROUP products, initiated a voluntary Level III recall of Intra-Aortic Balloon Counterpulsation Pumps (CARDIOSAVE Hybrid and CARDIOSAVE Rescue models). This action was announced on January 13, 2017, following a report dated December 28, 2016. The recall, overseen by the National Medical Products Administration (NMPA) of China, stems from the discovery that accidental dropping of the pumps' lithium batteries could cause them to emit smoke, odor, and sparks. This issue impacts 14 imported units, with 2 having been sold in China; no patient injuries or adverse events have been reported to date.

To address this potential safety concern, Maikewei (Shanghai) Medical Equipment Co., Ltd. is implementing several corrective actions. These include issuing a formal Medical Device Recall Notice to all customers affected by the issue. Additionally, warning labels will be prominently affixed to the lithium batteries to remind users to avoid dropping them. Furthermore, the company will provide users with free, reusable packaging boxes designed for the safe storage and transportation of the lithium batteries.

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