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  5. An Implantable Hypoglossal Nerve Stimulator Device Removal: Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse Generator due to Manufacturing Defect That Can Result in System Malfunctions
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An Implantable Hypoglossal Nerve Stimulator Device Removal: Inspire Medical Systems, Inc. Removes Inspire IV Implantable Pulse Generator due to Manufacturing Defect That Can Result in System Malfunctions

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. 

Affected Product 

  • Product Names: Inspire IV Implantable Pulse Generator (IPG)
  • Unique Device Identifier (UDI)/Model: UDI/DI 0855728005915/Model 3028
  • Lot/Serial Numbers: Includes thirty-two (32) devices of Model 3028 IPG. See Full List of Affected Devices.

What to Do

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

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.

Reason for Recall

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. There have been no reports of death. 

Device Use 

The Implantable Pulse Generator (IPG) is a key component of the Inspire Upper Airway Stimulation (UAS) system. The IPG stores therapy settings configured by a physician and delivers mild electrical stimulation to the hypoglossal nerve, which controls tongue muscles, to maintain airway patency during sleep. The IPG works together with external programmers that allow the physician to set and adjust the therapy parameters and the patient to control the therapy's activation and intensity.

Contact Information  

Customers in the U.S. with questions about this recall should 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]. 

Full List of Affected Devices 

  • AIR324492C
  • AIR324493C
  • AIR324494C
  • AIR324496C
  • AIR324500C
  • AIR324502C
  • AIR324503C
  • AIR324504C
  • AIR324506C
  • AIR324507C
  • AIR324508C
  • AIR324509C
  • AIR324510C
  • AIR324511C
  • AIR324515C
  • AIR324517C
  • AIR324518C
  • AIR324520C
  • AIR324521C
  • AIR324522C
  • AIR324523C

Additional FDA Resources  

Unique Device Identifier (UDI) 

The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through distribution to patient use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified, and problems potentially corrected more quickly. 

How do I report a problem? 

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program. 

 

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