China NMPA Product Recall - Intra-aortic balloon counterpulsation pump

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.