# China NMPA Product Recall - Cordis S.M.A.R.T.® Flex Nickel-Titanium Support System

Source: https://www.globalkeysolutions.net/records/china_product_recall/cordis-cashel/ee09e52c-ff7d-45b0-bc9d-53f513d582cf/
Source feed: China

> China NMPA product recall for Cordis S.M.A.R.T.® Flex Nickel-Titanium Support System by Cordis Cashel published March 17, 2017. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) published a notice on March 17, 2017, regarding 

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Contis (Shanghai) Medical Devices Co., Ltd. voluntarily recalls nickel-titanium stent systems.
- Company Name: Cordis Cashel
- Publication Date: 2017-03-17
- Product Name: Cordis S.M.A.R.T.® Flex Nickel-Titanium Support System
- Recall Level: Level 2 Recall
- Recall Reason: Global complaints indicate that the affected models (S. M. A. R. T.® Flex nickel-titanium stent systems, 5x200mm and 6x200mm) have a slightly higher number of complaints about stent release difficulties during use compared to other models, with some products experiencing release difficulties/failures.
- Discovering Company: Contis (Shanghai) Medical Devices Co., Ltd.
- Manufacturing Company: Cordis Cashel
- Summary: The National Medical Products Administration (NMPA) published a notice on March 17, 2017, regarding a voluntary, Level II recall initiated by Contis (Shanghai) Medical Devices Co., Ltd., a subsidiary of Cordis, a Cardinal Health company. This recall involves specific models of their S.M.A.R.T.® Flex Nickel-Titanium Stent System, notably SF05200MV, SF05200SV, SF06200MV, and SF06200SV. The primary reason for this action is a reported elevated incidence of stent release difficulties or complete failures during use, as evidenced by global complaints. Operating within the NMPA's medical device regulatory framework, Contis (Shanghai) Medical Devices Co., Ltd. formally reported the issue on February 23, 2017, and began implementing corrective measures. The required actions include a global recall of all affected product batches. In China, 57 imported units were specifically targeted. The company is actively notifying all distributors and customers to ensure the retrieval of any unused products, reinforcing patient safety and adherence to medical device standards. This proactive, voluntary recall highlights the manufacturer's dedication to resolving product performance concerns swiftly.

Company: https://www.globalkeysolutions.net/companies/cordis-cashel/c660aa92-8132-41ba-a142-fcd1453f36e3/