Z-2969-2018Class II

Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020

Name: Z-2969-2018 Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020
Creator: Inspire Medical Systems Inc.
Published: 2018-06-12
License: https://open.fda.gov/license/

Inspire Medical Systems Inc / initiated 2018-06-12 / Terminated / root cause: labeling and UDI

FDA source

Inspire Medical Systems Inc. began a recall of Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted... on 2018-06-12. FDA classified it as Class II and gives the reason as "Incorrect use-by date on the device registration/patient file labels". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2969-2018
Classification: Class II
Status: Terminated
Initiated: 2018-06-12
Posted: 2018-09-04
Terminated: 2019-05-21
Recalling firm: Inspire Medical Systems Inc
Product: Inspire II Model 3024 Implantable Pulse Generator (IPG) for Obstructive Sleep Apnea, Inspire Part #900-003-020, Product Usage: The device is an implanted component of the Inspire Upper Airway Stimulation (UAS) system. The UAS therapy is used to treat a subset of patients with moderate to severe obstructive sleep apnea (OSA).
Product code: MNQ Stimulator, Hypoglossal Nerve, Implanted, Apnea
Reason for recall: Incorrect use-by date on the device registration/patient file labels.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: The firm's sales team members called all of the affected implanting surgeons between 6/12-14/2018 to discuss the recall. The recalling firm issued "Dear Health Care Provider" letters dated 6/15/2018 via certified mail on 6/15/2018 to all implanting surgeons and hospital customers. The letter identified the affected product, problem and actions to be taken. For questions call 1-763-205-7974.
Quantity in commerce: 93 devices
Distribution: US Nationwide Distribution in the states of AL, AZ, CA, FL, GA, IL, KY, MA, MI, MN, MS, NY, OH, PA, TN, TX, VA, WA, and WI.
Product codes and lots: UDI 10855728005434. The incorrect Use By Date of 2018-01-14 can be found in the literature packet that is in the box with the sterile tray/IPG. The literature packet contains the product/patient manuals, device registration form, and the device registration label set. The 3 large label sticker set with the device registration label set contains the incorrect use-by date.. Affected serial numbers in the customer's stock: NCR202227H, NCR202230H, NCR202238H, NCR202244H, NCR202245H, NCR202246H, NCR202247H, NCR202252H, NCR202253H, NCR202254H, NCR202255H, NCR202259H, NCR202260H, NCR202261H, NCR202264H, NCR202266H, NCR202267H, NCR202268H, NCR202269H, NCR202270H, NCR202272H, NCR202273H, NCR202274H, NCR202275H, NCR202276H, NCR202277H, NCR202278H, NCR202279H, NCR202281H, NCR202282H, NCR202283H, NCR202284H, NCR202285H, NCR202287H, NCR202294H, NCR202306H, NCR202307H, NCR202314H, NCR202315H, NCR202317H, NCR202320H, NCR202324H, NCR202325H, NCR202328H, NCR202336H, NCR202337H, NCR202338H, NCR202339H, NCR202466H, and NCR202467H; Serial numbers implanted: NCR202231H, NCR202233H, NCR202234H, NCR202236H, NCR202237H, NCR202239H, NCR202241H, NCR202242H, NCR202249H, NCR202250H, NCR202251H, NCR202256H, NCR202257H, NCR202258H, NCR202262H, NCR202265H, NCR202286H, NCR202291H, NCR202293H, NCR202296H, NCR202297H, NCR202300H, NCR202301H, NCR202302H, NCR202303H, NCR202304H, NCR202309H, NCR202310H, NCR202311H, NCR202312H, NCR202313H, NCR202318H, NCR202321H, NCR202322H, NCR202323H, NCR202326H, NCR202327H, NCR202329H, NCR202330H, NCR202331H, NCR202332H, NCR202333H, and NCR202334H.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2969-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2969-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-12	2018-09-04

Product code MNQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)