# China NMPA Product Recall - Endurant II Stent Graft System

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/7bce7464-828e-4ac3-a95a-04ef142b7436/
Source feed: China

> China NMPA product recall for Endurant II Stent Graft System by Medtronic Inc. published November 18, 2021. Recall level: Level 1 Recall. Medtronic Inc. initiated a voluntary Class I recall of its Endurant II Stent Graft System, as report

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling its Endurant II Stent Graft System.
- Company Name: Medtronic Inc.
- Publication Date: 2021-11-18
- Product Name: Endurant II Stent Graft System
- Recall Level: Level 1 Recall
- Recall Reason: Insufficient weld penetration between the spindle and the sodium hypotube
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc. initiated a voluntary Class I recall of its Endurant II Stent Graft System, as reported by Medtronic (Shanghai) Management Co., Ltd. on November 18, 2021. The recall was prompted by a critical manufacturing defect involving insufficient weld penetration between the spindle and the hypo tube in certain product models and batches. This deficiency could potentially compromise the device's integrity and patient safety, leading to the highest level of recall classification. The National Medical Products Administration (NMPA) oversaw this recall action, ensuring compliance with established medical device regulations. While no specific inspection dates were provided in the document, the recall itself serves as a proactive measure taken by Medtronic to address a serious product quality issue. The company is required to identify and remove all affected Endurant II Stent Graft Systems from distribution and use, as detailed in the "Medical Device Recall List" and the "Medical Device Recall Event Report Form." This action underscores the stringent regulatory environment governing medical devices, where manufacturers are held accountable for product safety and efficacy. The voluntary nature of the recall reflects Medtronic's commitment to patient well-being and adherence to NMPA standards, addressing a critical design and manufacturing flaw that could have significant health implications.

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