The U.S. Food and Drug Administration (FDA) has issued a Class I recall that affects 32 units of Model 3028 Inspire IV Implantable Pulse Generators (IPGs) manufactured by Inspire Medical Device Systems Inc. The IPGs are implantable hypoglossal nerve stimulators used as a therapy for obstructive sleep apnea. The FDA’s designation as a Class I recall means a device can cause a serious injury or death if the patient continues to use it. So far, no serious injuries or deaths related to this device have been reported to the FDA. 

 

Patients are encouraged to contact their healthcare providers to schedule an appointment right away if they believe they have the affected implant. Patients can find the serial numbers for affected units on the FDA website. 

 

The Inspire Medical Systems Inc. is calling this action as a correction, which means that the company is fixing the problem with the device in the location where it is used or sold. In this instance, Inspire Medical Systems Inc., first took action on June 17, 2024, by contacting healthcare providers using this device to provide specific instructions to notify affected patients of the recall. The company further asked the healthcare providers to:

 

• Encourage patients to come back to the clinic for a follow up to ensure the devices are working properly. 

• Continue to monitor patients to check if the units are operating properly and consistently throughout the course of therapy. 

 

In an email to the Alliance of Sleep Apnea Partners (ASAP), Inspire Medical Systems has assured us that patient safety continues to be of paramount importance to Inspire and that they will continue to cooperate fully and follow-up, as appropriate, with the appropriate regulatory authorities, including the FDA, health care providers, and all potentially impacted patients.

 

For more information, including contacting Inspire Medical Systems Inc., please visit the FDA website.

 

If you have questions or concerns, please contact ASAP at info@apneapartners.org immediately.