China NMPA Product Recall - Programmable controller

The National Medical Products Administration (NMPA) released information on February 1, 2019, concerning a voluntary Class III recall by Medtronic, Inc. This recall, formally reported by Medtronic (Shanghai) Management Co., Ltd. on January 23, 2019, pertains to a potential short circuit issue in certain 26907 power supplies associated with the 29901 programmable controller, registered under National Medical Device Certificate No. 20152213885.

The core issue is a short circuit within the 19V DC connector, which can lead to overheating, smoke, melting, and potential disconnection from the programmer. Although the controller features a backup power supply, there is a risk of temporary burns from contact with the heating cable. Medtronic has recorded 14 global complaints related to this defect, though no injuries to patients or users have been reported. While the Class III recall extends to countries including the USA, Germany, and India, no affected products with the problematic power supply serial numbers were distributed in China. Therefore, the NMPA document confirms that no additional corrective actions are necessary within China.