# China NMPA Product Recall - Valiant Thoracic Stent Graft with the Captivia Delivery System

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/02917f49-79d7-4d62-b6f3-4d377196072d/
Source feed: China

> China NMPA product recall for Valiant Thoracic Stent Graft with the Captivia Delivery System by Medtronic Inc. published January 06, 2021. Recall level: Level 2. On January 6, 2021, the National Medical Products Administration (NMPA) announced a Class II volunta

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling its Valiant Thoracic Stent Graft with the Captivia Delivery System.
- Company Name: Medtronic Inc.
- Publication Date: 2021-01-06
- Product Name: Valiant Thoracic Stent Graft with the Captivia Delivery System
- Recall Level: Level 2
- Recall Reason: The Portuguese label for a specific model or batch of products is incorrect.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: On January 6, 2021, the National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Medtronic Inc. and reported by Medtronic (Shanghai) Management Co., Ltd. The recall pertains to the Valiant Thoracic Stent Graft with the Captivia Delivery System (Registration Certificate No.: 20143135591). The primary issue identified was an error in the Portuguese labeling of a specific model and batch of these products. This action underscores Medtronic's commitment to product safety and regulatory compliance. The NMPA's involvement ensures public awareness and oversight of such medical device actions. Detailed specifications of the affected product models and batches are available in the "Medical Device Recall Event Report Form." This voluntary recall demonstrates the importance of accurate product information to safeguard patient health and maintain confidence in medical devices. The company is taking proactive steps to address the labeling discrepancy, ensuring that all product information aligns with required standards.

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