China NMPA Product Recall - Subcutaneous implantable defibrillator electrode lead

On December 3, 2020, the National Medical Products Administration (NMPA) announced a Class II voluntary recall initiated by Boston Scientific International Medical Trading (Shanghai) Co., Ltd. The recall pertains to specific models of their subcutaneous implantable defibrillator leads, identified under Registration Certificate No.: 20153212409. The company reported that since 2017, approximately 47,000 units of the model 3501 leads have been distributed worldwide. A critical safety concern emerged with 27 documented reports of lead breakage occurring at the distal end of the proximal sensing electrode. This malfunction is serious as a broken lead compromises the device's primary function, preventing it from delivering necessary defibrillation therapy. Additionally, the defect triggers a high-impedance alarm, alerting users to the failure. In response to these reported issues and to ensure patient safety, Boston Scientific International Medical Trading (Shanghai) Co., Ltd. proactively initiated the recall. The decision aligns with the regulatory oversight of the NMPA, particularly through the Shanghai Municipal Drug Administration, to address medical device safety promptly. Detailed information regarding specific affected product models, specifications, and batch numbers is available in the accompanying "Medical Device Recall Event Report Form." This action underscores a commitment to product integrity and patient well-being in the face of identified performance deficiencies.