China NMPA Product Recall - Implantable cardioverter-defibrillator (ICD); Implantable cardioverter-defibrillator (ICD); Implantable cardioverter-defibrillator (ICD)

Medtronic (Shanghai) Management Co., Ltd. initiated a voluntary Class 1 recall on April 16, 2021, for specific implantable cardiac resynchronization therapy defibrillators (ICD). This action, overseen by the National Medical Products Administration (NMPA) and announced by the Shanghai Municipal Drug Administration, addresses a manufacturing issue identified through continuous monitoring. The primary concern is that approximately 0.22% of devices containing Blackwell batteries, manufactured before July 2017, may prematurely display a "recommended replacement time" warning. This issue shortens the interval between the initial warning and the device's "service termination," making it more prevalent in devices with low usage rates. While no permanent patient injuries or fatalities have been reported due to this anomaly, the company is undertaking this recall to ensure patient safety and device reliability. The specific affected models, specifications, and batches are detailed in the accompanying Medical Device Recall Event Report Form, requiring professional adherence to the recall instructions for affected products.