# China NMPA Product Recall - Model 5388 External Temporary Cardiac Pacemaker

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/ded9da10-8ee1-46c2-a2e4-35659752bf1c/
Source feed: China

> China NMPA product recall for Model 5388 External Temporary Cardiac Pacemaker by Medtronic Inc. published December 07, 2010. Recall level: . Medtronic Inc. initiated a voluntary recall of its Model 5388 External Temporary Pacemaker, as annou

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is recalling its Model 5388 temporary external pacemaker.
- Company Name: Medtronic Inc.
- Publication Date: 2010-12-07
- Product Name: Model 5388 External Temporary Cardiac Pacemaker
- Recall Reason: Some products may fail to power on or shut down unexpectedly due to high-resistance contacts on the electronic circuit board.
- Discovering Company: Medtronic China Ltd. and Medtronic Medical Technology Service (Shanghai) Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc. initiated a voluntary recall of its Model 5388 External Temporary Pacemaker, as announced by the National Medical Products Administration (NMPA) on December 7, 2010. The recall stems from a manufacturing defect: approximately 6,000 of 36,000 units globally contain a high-impedance contact on the electronic circuit board. This defect poses a risk of the device failing to power on or unexpectedly shutting down during use.

As of October 4, 2010, Medtronic had received 114 reports of devices shutting down shortly after startup and 2 reports of devices powering off during operation. Crucially, no patient injuries related to this issue have been reported. Medtronic has since developed a design upgrade to resolve the identified problem.

Under the guidance of the NMPA (formerly SFDA), Medtronic's required actions involve contacting affected customers to facilitate the return of devices for repair. While awaiting repair, which is estimated to take 2-4 weeks, customers may continue to use their devices if they are functioning normally. This proactive measure ensures product quality and patient safety, demonstrating Medtronic's commitment to addressing identified product deficiencies.

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