# China NMPA Product Recall - Thrombectomy Console (Thrombus Aspiration Control System)

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/60998b5e-e5c3-4ce5-b78a-7c73bb3aa9e8/
Source feed: China

> China NMPA product recall for Thrombectomy Console (Thrombus Aspiration Control System) by Boston Scientific Corporation published April 06, 2017. Recall level: III. Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Level III

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. is voluntarily recalling its thrombus aspiration control system.
- Company Name: Boston Scientific Corporation
- Publication Date: 2017-04-06
- Product Name: Thrombectomy Console (Thrombus Aspiration Control System)
- Recall Level: III
- Recall Reason: Boston Scientific has received market feedback regarding issues with the Thrombectomy Console foot switch becoming stuck during use, leading to unexpected and continuous operation. When this occurs, please follow the troubleshooting steps in the operating guide. You can try manually releasing the foot switch or turning off the controller to stop the catheter from working. A review of complaints indicates that this issue can prolong procedure time due to troubleshooting and catheter removal actions, and in the most serious cases, may lead to procedure cancellation if the problem is not resolved and no alternative is available. To date, no adverse patient events have been reported due to such complaints.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific Corporation
- Summary: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Level III recall on April 6, 2017, for its Thrombus Aspiration Control System, model 5000A. This action was prompted by market feedback indicating that the device's foot switch could become stuck during use, leading to unexpected continuous operation. This malfunction poses a risk of prolonged procedure times, necessitates troubleshooting, and in severe cases, could lead to procedure cancellation if unresolved. While 95 units were manufactured and 54 sold in China, no adverse patient events related to this issue have been reported to date. Operating under the oversight of the National Medical Products Administration (NMPA), Boston Scientific is taking corrective action by issuing a notification letter to all affected customers. This letter will provide detailed troubleshooting methods for the foot switch issue and outline the specific actions users should take when encountering the problem to ensure patient safety and operational efficiency.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-corporation/29488af7-a1d7-4d3b-a8ab-1f12fddb5e4b/