Inspire recalls implantable pulse generator

MINNEAPOLIS, Minn. – Inspire Medical Systems is voluntarily recalling its Inspire IV Implantable Pulse Generator (IPG) Model 3028 due to a manufacturing defect that 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. There have been no reported injuries or death. Health care providers should: 

• Notify affected patients of this voluntary recall. 

• Schedule an appointment for the patient to check if their Inspire therapy is working properly by analyzing signals and resistance. Keep an eye out for any changes in the stimulation, lack of therapy effectiveness, or problems with turning the therapy on. 

• Keep doing regular check-ups and tests to analyze signals and resistance at every visit, as these simple tests can spot issues with the device without needing surgery. 

Patients should:  

• Contact your health care provider as soon as possible to make sure you have a routine office visit scheduled. 

• If you have already been contacted by your health care provider, follow-up as scheduled.   

• Attend your scheduled office visit. Routine non-invasive diagnostic monitoring identifies this potential IPG defect.   

• If you have new symptoms or re-occurrence of symptoms like fatigue, perceived sleepiness, snoring problems, etc., contact your sleep physician for a comprehensive evaluation, which may include a polysomnography. 

• If your provider determines a revision surgery is necessary to replace the IPG, you may contact Inspire’s Patient and Physician Services at 1-844-OSA-HELP for further information.