# China NMPA Product Recall - Implantable cardiac resynchronization therapy pacemaker, implantable cardiac pacemaker

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-corporation/20380c8d-5fbe-4d9f-b33e-5198524c0524/
Source feed: China

> China NMPA product recall for Implantable cardiac resynchronization therapy pacemaker, implantable cardiac pacemaker by Boston Scientific Corporation published October 30, 2018. Recall level: Level 2 Recall. Boston Scientific International Medical Trading (Shanghai) Co., Ltd. initiated a voluntary Class II 

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. is voluntarily recalling implantable cardiac resynchronization therapy pacemakers and implantable cardiac pacemakers.
- Company Name: Boston Scientific Corporation
- Publication Date: 2018-10-30
- Product Name: Implantable cardiac resynchronization therapy pacemaker, implantable cardiac pacemaker
- Recall Level: Level 2 Recall
- Recall Reason: Hydrogen-induced premature battery depletion increases the likelihood of the machine needing to be replaced earlier.
- 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 Class II recall for specific implantable cardiac resynchronization therapy pacemakers and implantable cardiac pacemakers. The manufacturer, Cardiac Pacemakers, Inc., a subsidiary of Boston Scientific Corporation, identified accelerated battery depletion caused by hydrogen induction in approximately 2,900 devices, which increases the risk of premature device replacement. The affected models include U128, U228, L200, L221, L300, L301, L321, L100, L101, and L121. This action was reported to China's National Medical Products Administration (NMPA) on September 14, 2018, and published on October 30, 2018.

Required actions include recommending routine patient follow-up procedures, such as monitoring via the LATITUDE™ NXT remote patient management system, at intervals no longer than six months to identify device behavior. To date, no injuries have been reported related to this issue. Boston Scientific clarified that this field action primarily affects products outside of China. Therefore, while reported to the NMPA, the company stated no further domestic recall measures, investigation reports, or recall plans would be submitted within China beyond the initial notification.

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