# China NMPA Product Recall - Covered scaffold system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/ef0c9253-fc01-4531-b4dc-7a719dd8ad1a/
Source feed: China

> China NMPA product recall for Covered scaffold system by Medtronic (Shanghai) Management Co., Ltd. published January 18, 2022. Recall level: Level 2 Recall. Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class II recall of its covered stent

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. is voluntarily recalling its covered stent system.
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2022-01-18
- Product Name: Covered scaffold system
- Recall Level: Level 2 Recall
- Recall Reason: Medtronic's complaint investigation revealed that the tapered end of a specific batch of a certain model of coated support system may detach from the delivery system. Further investigation indicated that the issue was caused by improper handling by manufacturing personnel during the production of the tapered end assembly by Medtronic's supplier; the estimated incidence of tapered end detachment is 0.002%.
- 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 its covered stent systems, as announced by the National Medical Products Administration (NMPA) on January 18, 2022. This action pertains to specific batches of products (Registration Certificate Nos.: 20153132422; 20173137035). The recall was triggered by a complaint investigation which revealed that the conical tip of certain stent systems could detach from the delivery mechanism during surgical deployment. Further inquiry identified the root cause as improper handling by a supplier's personnel during the manufacturing of the conical tip assembly. The estimated incidence of this issue is very low at 0.002%. As of December 9, 2021, five global complaints regarding tip separation were received, with no reported adverse events in the Chinese market. Medtronic determined that patients who had the stent successfully deployed face no additional risk or require further measures. Under the NMPA's regulatory framework, the company's required action is to recall the affected product models and batch numbers, with detailed information available in the "Medical Device Recall Event Report Form."

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