Recall: Inspire IV Implantable Pulse Generator (IPG) Model 3028

On July 8, the FDA announced that Inspire Medical Systems, Inc. removed the Inspire IV Implantable Pulse Generator due to a manufacturing defect that can result in system malfunctions.

On June 17, 2024, Inspire Medical Inc. sent all affected customers an URGENT Medical Device Correction recommending the following actions:

For Healthcare Providers:

• 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:

• Contact your healthcare provider as soon as possible to make sure you have a routine office visit scheduled.
• If you have already been contacted by your healthcare 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 [1-844-672-4357] for further information.

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.

The use of affected product may cause serious adverse health consequences, including stimulation below normal therapeutic levels and/or early depletion of the battery (resulting in - loss of therapy), inappropriate or inconsistent stimulation effect, painful stimulation or perceived shocking sensation and death. 

There have been no reported injuries and no reports of death.