# China NMPA Product Recall - Programmable controller

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/36ddc9ea-c50e-46c2-8fe0-6c693420a7d1/
Source feed: China

> China NMPA product recall for Programmable controller by Medtronic Inc. published February 01, 2019. Recall level: Level 3 Recall. The National Medical Products Administration (NMPA) released information on February 1, 2019, concer

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic, Inc. voluntarily recalls programmable controllers.
- Company Name: Medtronic Inc.
- Publication Date: 2019-02-01
- Product Name: Programmable controller
- Recall Level: Level 3 Recall
- Recall Reason: Medtronic has identified a potential short-circuit issue in some Model 26907 power supplies connected to the Model 29901 programmable controller. The failure mode of the power supply is a short circuit in the 19-volt DC connector, which can cause the connector to heat up, produce smoke, melt, and in some cases disconnect from the programmable controller. It is important to note that the Encore programmable controller is designed with a backup power supply that can keep the controller running for at least 20 minutes before shutdown. Potential injuries due to the short circuit include temporary burns or potential injury from close contact with the cable plug when the short circuit is causing it to heat up. Medtronic has identified 14 complaints of short circuits related to this recall worldwide, with no reported injuries to patients or users.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/