# China NMPA Product Recall - Implantable Cardiac Monitor (ICM), Transcatheter Leadless Pacing System, Implantable Pacemaker

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/0765066e-9fc8-42dd-861b-58afc5abb133/
Source feed: China

> China NMPA product recall for Implantable Cardiac Monitor (ICM), Transcatheter Leadless Pacing System, Implantable Pacemaker by Medtronic Inc. published October 23, 2023. Recall level: Level 3 Recall. Medtronic Inc., in collaboration with Medtronic (Shanghai) Management Co., Ltd., has initiated a vol

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is issuing a voluntary recall for its implantable cardiac event monitors, transcatheter leadless pacing systems, and implantable pacemakers.
- Company Name: Medtronic Inc.
- Publication Date: 2023-10-23
- Product Name: Implantable Cardiac Monitor (ICM), Transcatheter Leadless Pacing System, Implantable Pacemaker
- Recall Level: Level 3 Recall
- Recall Reason: For certain products in certain countries/regions, the electronic instruction manual (e-IFU) is not published on the electronic manuals website.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc., in collaboration with Medtronic (Shanghai) Management Co., Ltd., has initiated a voluntary Class III recall, as announced by the National Medical Products Administration (NMPA) on October 23, 2023. The recall addresses a critical issue where electronic instruction manuals (e-IFUs) for specific implantable medical devices were not published and accessible on the company's e-Manuals website in certain countries and regions. The affected products include implantable ECG event monitors (ICMs), transcatheter leadless pacing systems, and implantable cardiac pacemakers. This non-compliance with documentation accessibility standards is the primary concern. Under the NMPA's regulatory framework, Medtronic is required to conduct this voluntary recall to ensure that all necessary product information is available to users. While a detailed list of affected models and specifications is available in the 'Medical Device Recall Event Report Form,' the immediate action involves retrieving these devices to rectify the information gap, ensuring proper device handling and patient safety through complete documentation.

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