China NMPA Product Recall - Subcutaneous implantable cardioverter defibrillator

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."