INDIANA- Inspire Medical Systems Inc. is recalling Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect. This defect can cause system malfunctions after implantation, leading to electrical leakage in the sensing circuit. As a result, patients may need revision surgery to replace the IPG and restore therapy.
This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. If you continue to use this device, you may cause serious injury or death.
