# China NMPA Product Recall - Implantable Bradycardia Pacemakers

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-international-medical-trade-shanghai-co-ltd/c929f9bb-57d2-46a5-8fd6-7047ed01dd7a/
Source feed: China

> China NMPA product recall for Implantable Bradycardia Pacemakers by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. published August 20, 2019. Recall level: Level 2 Recall. On August 20, 2019, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. announced a

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. is voluntarily recalling the implantable Bradycardia Pacemakers.
- Company Name: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Publication Date: 2019-08-20
- Product Name: Implantable Bradycardia Pacemakers
- Recall Level: Level 2 Recall
- Recall Reason: Several reports have been received regarding intermittent oversensing caused by minute ventilation sensor signals in certain models of implantable cardiac pacemakers and implantable cardiac resynchronization therapy pacemakers. Investigations confirmed that a transient high-impedance state may occur at the electrode leads or the pacemaker-lead connection. When the minute ventilation sensor is activated, this transient high-impedance state can subsequently alter the minute ventilation sensor signal, leading to oversensing in the right atrium or right ventricle.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Summary: On August 20, 2019, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. announced a voluntary Class II recall impacting specific models of implantable bradycardia pacemakers and cardiac resynchronization therapy pacemakers. This recall, reported to the Shanghai Food and Drug Administration and managed under the National Medical Products Administration (NMPA) framework, was prompted by several reports of intermittent oversensing in the affected devices. The core problem identified involves a transient high impedance state that can develop at the electrode leads or their connection points with the pacemaker. This electrical anomaly, when the minute ventilation sensor is activated, has the potential to alter the sensor signal significantly. Such alteration then leads to unintended oversensing within the right atrial or right ventricular channels, which can be observed during intracardiac electrocardiography. In response to these critical performance issues, Boston Scientific is proactively recalling products with Registration Certificate Nos.: 20183120513, 20183120512, and 20183120509. The required action is a voluntary recall designed to address these device malfunctions and uphold product reliability and patient safety standards.

Company: https://www.globalkeysolutions.net/companies/boston-scientific-international-medical-trade-shanghai-co-ltd/bc370948-4fe0-497a-93dd-bbac3a59dd56/