China NMPA Product Recall - Centrifugal pump blood control and detection system

Medtronic (Shanghai) Management Co., Ltd. initiated a Class I voluntary recall, published on March 29, 2021, for its centrifugal pump blood control detection system. This action was prompted by a critical issue stemming from a supplier's discontinuation of a key component. The original DC-DC converter assembly (PN A09674003) was replaced with a different spare part (PN M975344A001). Investigations revealed that this replacement component had a different maximum voltage input, leading to inadequate voltage specifications for the device's main system controller module (PN 90909004). The identified malfunction poses several significant risks during device operation. These include the potential for the instrument to shut down, causing the pump to stop rotating, and user interface malfunctions such as a blank screen. Furthermore, there is a risk of smoke and a burning odor emanating from the device both before and during use. This recall is being conducted under the oversight of China's National Medical Products Administration. Medtronic has advised users to consult the centrifugal pump blood control monitoring system operation and reference manual for detailed procedures. Crucially, the company has confirmed that, as of the recall date, no patient injuries or adverse events related to this specific issue have been reported globally. The recall targets specific models, specifications, and batches, with further details available in the "Medical Device Recall Event Report Form."