# China NMPA Product Recall - Subcutaneous implantable cardioverter defibrillator

Source: https://www.keypedia.com/records/china_product_recall/boston-scientific-bsc/c6a584cc-df52-4119-a031-4e2de29388ef
Source feed: China

> China NMPA product recall for Subcutaneous implantable cardioverter defibrillator by Boston Scientific (BSC) published December 03, 2020. Recall level: Level 2 Recall. The National Medical Products Administration (NMPA) announced on December 3, 2020, a voluntary Class

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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 (BSC)
- Publication Date: 2020-12-03
- Product Name: Subcutaneous implantable cardioverter defibrillator
- Recall Level: Level 2 Recall
- Recall Reason: During subcutaneous implantable cardioverter defibrillators (ICDs), voltage overload may occur. Due to differences in head assembly processes, a very small pathway may be formed that allows moisture to enter, leading to a short circuit during the ICD process.
- Discovering Company: Boston Scientific International Medical Trade (Shanghai) Co., Ltd.
- Manufacturing Company: Boston Scientific (BSC)
- Summary: The National Medical Products Administration (NMPA) announced on December 3, 2020, a voluntary Class II recall initiated by Boston Scientific International Medical Trading (Shanghai) Co., Ltd. for certain subcutaneous implantable cardioverter-defibrillators. This action stems from six global reports confirming voltage overload during electrical stimulation of these devices. The fundamental issue was traced to manufacturing variations in the head assembly processes. These discrepancies could create a microscopic pathway, permitting moisture intrusion into the device, which in turn leads to a short circuit during electrical stimulation, potentially compromising patient safety and device efficacy. Under the regulatory guidance of the NMPA and publicized by the Shanghai Municipal Drug Administration Website, Boston Scientific is systematically withdrawing affected devices identified by specific serial numbers and Registration Certificate No.: 20153212410. This recall underscores the company's responsibility to address product performance and uphold rigorous medical device safety protocols. Comprehensive details regarding the affected product models, specifications, and batches are provided in the accompanying "Medical Device Recall Event Report Form."

Company: https://www.keypedia.com/companies/boston-scientific-bsc/fa008564-c7a1-4881-9144-46f9e23d75e0