# China NMPA Product Recall - Medtronic PRO+ Transcatheter Aortic Valve System

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/ec017771-34d6-4260-931d-528017a371d2/
Source feed: China

> China NMPA product recall for Medtronic PRO+ Transcatheter Aortic Valve System by Medtronic Inc. published December 23, 2024. Recall level: Level 3 Recall. Medtronic Inc. initiated a voluntary Class III recall of its Transcatheter Aortic Valve System, spec

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling its transcatheter aortic valve system.
- Company Name: Medtronic Inc.
- Publication Date: 2024-12-23
- Product Name: Medtronic PRO+ Transcatheter Aortic Valve System
- Recall Level: Level 3 Recall
- Recall Reason: The product has regulatory compliance issues in Thailand.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc. initiated a voluntary Class III recall of its Transcatheter Aortic Valve System, specifically the Medtronic PRO+ System (National Medical Device Registration Certificate No. 20243130221). The recall was publicly reported by Medtronic (Shanghai) Management Co., Ltd. on December 23, 2024, in coordination with the National Medical Products Administration (NMPA) of China. The reason for this action stems from identified regulatory compliance issues encountered in Thailand. It is important to note that the specific products implicated in this recall were not distributed or imported into China, as confirmed by Medtronic. The recall details, including specific models, specifications, and batch numbers, are documented in an accompanying 'Medical Device Notification Form' and 'Medical Device Recall Event Report Form'. This proactive measure aligns with global regulatory standards for medical device oversight, even though the affected products did not reach the Chinese market, highlighting the international scope of medical device regulatory reporting and manufacturer responsibility.

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