# China NMPA Product Recall - Single Chamber Temporary External Pacemaker (Model: 53401)

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/61d63bf7-bdc9-4e9b-84cd-3c6cb70d5df0/
Source feed: China

> China NMPA product recall for Single Chamber Temporary External Pacemaker (Model: 53401) by Medtronic (Shanghai) Management Co., Ltd. published April 23, 2021. Recall level: Level 3. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of its Single Chamb

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. is voluntarily recalling its Single Chamber Temporary External Pacemaker.
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2021-04-23
- Product Name: Single Chamber Temporary External Pacemaker (Model: 53401)
- Recall Level: Level 3
- Recall Reason: The Chinese label on the single-chamber external temporary pacemaker states "Usage period: 8 years" which differs from the "Usage period: 7 years" stated in the Chinese instruction manual. The Chinese label lists an 8-year usage period, not the correct 7 years. This discrepancy is also present on the product's device label, the Chinese label on the outer packaging, and the Chinese traceability label.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class III recall of its Single Chamber Temporary External Pacemaker (model: 53401), as announced by the National Medical Products Administration (NMPA) on April 23, 2021. This action followed a customs inspection on October 20, 2020, which identified a labeling inconsistency.The primary issue concerned a discrepancy in the stated "Usage Period" for the pacemaker. While the Chinese label, device label, outer packaging, and traceability label indicated an "8 years" usage period, the Chinese instruction manual correctly specified "7 years." Medtronic's investigation confirmed the correct usage period to be 7 years, which denotes the duration for which the company provides repair and maintenance services. The product can still be used safely beyond this period, provided regular safety checks are performed.Medtronic clarified that this labeling error poses no risk to patients, as the usage period for all products currently on the market is approximately one year. As of March 26, 2021, no complaints or adverse events related to this specific labeling issue had been reported globally. The company is taking necessary steps to address the discrepancy and manage the recall under the NMPA's regulatory oversight.

Company: https://www.globalkeysolutions.net/companies/medtronic-shanghai-management-co-ltd/e5ba243d-a47a-4442-84d4-1e11f92f75e2/