China NMPA Product Recall - Implantable devices

The National Medical Products Administration (NMPA) announced a Class I voluntary recall initiated by Medtronic Inc. and its subsidiary, Medtronic (Shanghai) Management Co., Ltd. Published on May 30, 2023, this recall addresses a critical performance issue identified in a specific batch of Medtronic’s implantable devices. The primary concern involves certain implantable cardioverter defibrillators and other related implantable devices. It was discovered that these devices exhibited reduced or, in some cases, a complete absence of energy delivery during high-pressure therapy sessions. This malfunction was specifically observed when the programming setting was configured to AX>B. Such a failure in energy delivery during critical therapy could pose significant health risks to patients. In response to this serious defect, Medtronic Inc. is voluntarily recalling the affected products. A Class I recall designation indicates that there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. The specific models, specifications, and further details regarding the affected devices are provided in the accompanying “Medical Device Recall Event Report Form” and an attached Medtronic document. This proactive measure ensures patient safety by removing potentially defective devices from circulation.