Inspire Medical Systems Inc.: 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).

Recall number

Z-2969-2018

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).

Status

Terminated

Initiated

2018-06-12

Posted

not on file

Terminated

2019-05-21

Reason

Incorrect use-by date on the device registration/patient file labels.

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

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.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

["P130008"]

Product code

MNQ

Firm FEI

3007666314

Firm city

Maple Grove

Firm state

MN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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