# China NMPA Product Recall - Subcutaneous implantable cardioverter defibrillator

Source: https://www.globalkeysolutions.net/records/china_product_recall/boston-scientific-international-medical-trade-shanghai-co-ltd/0bb42ace-4895-4515-b950-db1371a117ce/
Source feed: China

> China NMPA product recall for Subcutaneous implantable cardioverter defibrillator by Boston Scientific International Medical Trade (Shanghai) Co., Ltd. published December 03, 2020. Recall level: Level 2 Recall. Boston Scientific International Medical Trade (Shanghai) Co., Ltd. initiated a voluntary Class II re

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Boston Scientific International Medical Trading (Shanghai) Co., Ltd. is voluntarily recalling its subcutaneous implantable cardioverter defibrillator.
- Company Name: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Publication Date: 2020-12-03
- Product Name: Subcutaneous implantable cardioverter defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: There may be an increased possibility that the battery will be prematurely depleted due to the low-voltage capacitor.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Summary: Boston Scientific International Medical Trade (Shanghai) Co., Ltd. initiated a voluntary Class II recall of its subcutaneous implantable cardioverter defibrillators on December 3, 2020. This action, reported via the National Medical Products Administration (NMPA), addresses a critical product deficiency. The primary concern is an increased battery depletion rate stemming from issues with low-voltage capacitors within the devices. This defect could potentially compromise the functionality and longevity of the defibrillators, which are essential medical devices. The recall specifically targets products within a defined range of serial numbers, indicating a focused effort to mitigate risks. While the document does not detail specific inspection dates, the recall itself is a proactive measure taken by Boston Scientific to ensure patient safety and product reliability under the regulatory oversight of the NMPA. Affected customers and healthcare providers are directed to consult the "Medical Device Recall Event Report Form" for precise details on the models, specifications, and batches involved in this important corrective action.

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