# China NMPA Product Recall - Covered scaffold system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/596d3a54-50a6-476b-b6d8-d7feaf82aee0/
Source feed: China

> China NMPA product recall for Covered scaffold system by Medtronic (Shanghai) Management Co., Ltd. published May 08, 2017. Recall level: Level II. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of specific covered 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. voluntarily recalls its covered stent system.
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2017-05-08
- Product Name: Covered scaffold system
- Recall Level: Level II
- Recall Reason: Certain models and batches of covered stents have higher membrane permeability, and endoleak may be observed during implantation.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of specific covered stent systems, as announced by the National Medical Products Administration (NMPA) on May 8, 2017. This crucial action stemmed from a identified manufacturing issue where certain models and batches of the covered stents exhibited higher than acceptable membrane permeability. This defect poses a significant concern as it could lead to endoleaks being observed during the stent implantation surgery, potentially impacting patient safety and the intended therapeutic outcome. While specific inspection dates are not detailed, the recall date signifies the company's prompt response to the quality concern. Operating under the NMPA's regulatory oversight, the company's required action was to systematically recall these affected products from the market. Further comprehensive details regarding the specific models, specifications, and batch numbers involved in this recall are formally documented in the accompanying "Medical Device Recall Event Report Form" referenced by the NMPA. This proactive measure underscores Medtronic's commitment to product quality and patient safety within the established regulatory framework.

Company: https://www.globalkeysolutions.net/companies/medtronic-shanghai-management-co-ltd/e5ba243d-a47a-4442-84d4-1e11f92f75e2/