# China NMPA Product Recall - Covered stent system, covered stent balloon catheter

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/c34c04be-5905-4944-89ee-ff8c25c05d8a/
Source feed: China

> China NMPA product recall for Covered stent system, covered stent balloon catheter by Medtronic Inc. published May 16, 2019. Recall level: Level 2 Recall. Medtronic Inc., through its agent Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary C

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is voluntarily recalling its covered stent system and covered stent balloon catheter.
- Company Name: Medtronic Inc.
- Publication Date: 2019-05-16
- Product Name: Covered stent system, covered stent balloon catheter
- Recall Level: Level 2 Recall
- Recall Reason: Our company has discovered a potential risk in a commercial order from Canada, which may have been incorrectly processed as a demonstration order and shipped to a hospital. Four products in this order (model numbers ETUF3614C102EE, ETLW1616C124EE, AB46, and OC124, with OCL24 lacking a registration certificate in China) were processed as demonstration orders, including damaging sterile packaging and affixing "Not for Human Use" labels before being shipped to the hospital. Three of the four products (model numbers ETUF3614C102EE, ETLW1616C124EE, and OCL24, with OCL24 lacking a registration certificate in China) were implanted in one patient. To date, no reports of patient harm have been received. This issue does not affect other product orders.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc., through its agent Medtronic (Shanghai) Management Co., Ltd., initiated a voluntary Class II recall, reported to China's National Medical Products Administration (NMPA) on May 9, 2019, with the NMPA publishing the notification on May 16, 2019. The recall concerns Medtronic Covered Stent Systems (Registration Certificate No. 20153462422) and Covered Stent Balloon Catheters (Registration Certificate No. 20173771836).

The issue stemmed from a procedural error originating in Canada, where a commercial order containing specific product models, including ETUF3614C102EE, ETLW1616C124EE, AB46, and OCL24, was incorrectly processed as a demonstration order and sent to a hospital. A significant violation involved the OCL24 model, which lacks a registration certificate in China; its sterile packaging was compromised and it was labeled "Not for Human Use" before shipment. Subsequently, three of these products were implanted in one patient, though no patient harm has been reported.

Under the NMPA regulatory framework, Medtronic reported this event. However, since no affected products were sold within China, no further corrective actions are required in China. The company confirmed that this incident does not affect other product categories.

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