# China NMPA Product Recall - Sentrant Introducer Sheath, Endurant II Stent Graft System

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/c743cdca-6c37-4070-b9cb-281ce5d51d32/
Source feed: China

> China NMPA product recall for Sentrant Introducer Sheath, Endurant II Stent Graft System by Medtronic Inc. published July 04, 2023. Recall level: Level 3 Recall. On July 4, 2023, Medtronic Inc. initiated a voluntary Class III recall for specific medical devices,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling its vascular guidance sheaths and covered stent systems.
- Company Name: Medtronic Inc.
- Publication Date: 2023-07-04
- Product Name: Sentrant Introducer Sheath, Endurant II Stent Graft System
- Recall Level: Level 3 Recall
- Recall Reason: Due to a procedural error, users of certain products in some countries/regions are unable to obtain the correct instruction manuals, which may pose a risk to the safety and proper use of the products.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: On July 4, 2023, Medtronic Inc. initiated a voluntary Class III recall for specific medical devices, overseen by the National Medical Products Administration (NMPA). The affected products include the Sentrant Introducer Sheath (Registration Certificate 20153031891) and the Endurant II Stent Graft System (Registration Certificate 20153132422). This action, reported by Medtronic (Shanghai) Management Co., Ltd., was due to a process error that prevented users in certain regions from accessing the correct instructions for use. This critical oversight posed a potential risk to both the safety and proper application of these medical products. While the document does not specify inspection dates, the recall ensures that Medtronic takes necessary corrective measures to address the unavailability of crucial user information. Comprehensive details regarding the specific models, specifications, and batch numbers involved are available in the official "Medical Device Recall Event Report Form." This incident underscores the importance of accessible and accurate product information for safe medical device usage.

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