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Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse Generator due to Manufacturing Defect That Can Result in System Malfunctions

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. This device may cause serious injury or death if you continue to use it.    

Questions?

If you have questions about this recall, contact Inspire Medical Systems, Inc. at 763-205-7970 or contact Inspire’s Patient and Physician Services at 1-844-OSA-HELP [1-844-672-4357].