China NMPA Product Recall - Subcutaneous implantable cardiodefibrillation electrode lead

The National Medical Products Administration (NMPA) has announced a supplemental Class I recall initiated by Boston Scientific Corporation, impacting its Subcutaneous Electrode and Implantable Defibrillation Electrode Leads. This recall, originally issued on January 28, 2021, with updated information released on July 6, 2021, addresses a critical safety concern. The primary issue identified is the potential for breakage at the distal end of the proximal sensing electrode within specific models and batches of these devices. Such a malfunction could lead to the inability to deliver essential defibrillation treatment, posing a serious health risk to patients. Boston Scientific International Medical Trading (Shanghai) Co., Ltd. reported this defect. In response to this significant product flaw, Boston Scientific Corporation has implemented a design enhancement for its Subcutaneous Electrode Leads. These newly enhanced leads are intended to serve as replacements for the affected or original devices currently in use. The regulatory action, overseen by the NMPA, classifies this as a Class I recall, indicating the highest level of recall due to the serious health consequences associated with the product defect. Affected product numbers, specifications, and batches are detailed in the accompanying "Medical Device Recall Event Report Form."