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

Medtronic (Shanghai) Management Co., Ltd. announced a voluntary Class II recall for specific models of its Implantable Cardiac Resynchronization Therapy Defibrillators (ICD) and Implantable Resynchronization Therapy (IRPT) Cardioverter-Defibrillators (IDFs). This action, reported by the Shanghai Municipal Drug Administration under the National Medical Products Administration (NMPA) framework on March 16, 2021, addresses a performance issue identified through continuous monitoring and data modeling. The primary concern is that approximately 0.22% of devices containing Blackwell batteries, manufactured before July 2017, are exhibiting an earlier-than-expected 'recommended replacement time' warning. Furthermore, the period between this warning and the device's 'service termination' is shorter than anticipated, particularly affecting devices with low usage rates. While no permanent patient injuries or fatalities have been attributed to this issue, Medtronic is initiating the recall to address the potential malfunction. Affected products include models IRFTA 20193121539, IRFTA 20193121722, and IRFTA 20193121536, with comprehensive details available in the accompanying recall event report.