Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Inspire Medical Systems medical devices: approvals, recalls and adverse events

Stock: INSP. Includes companies and brands it has bought. Official US government data, updated September 2026.

510(k) clearances

De Novo: 0

PMA approvals

134 supplements

Recalled products

1 class I

Adverse event reports

3,492

4 deaths reported

How many recalls does Inspire Medical Systems have?

Inspire Medical Systems has 6 recalled medical device products in 4 recall actions in the records, 1 of them class I (the most serious kind). The newest recall started on May 11, 2026. In 2024 it had 3 recalled products.

How many medical devices has Inspire Medical Systems had cleared or approved?

0 510(k) clearances, 0 De Novo grants and 1 original PMA approvals for high-risk devices, plus 134 PMA supplements (changes to approved devices). The newest decision was on Aug 28, 2026.

How many adverse event reports name Inspire Medical Systems devices?

3,492 reports in total: 4 deaths, 3,335 injuries and 151 malfunctions were reported. 958 reports were received in 2025. A report alone does not show that the device caused the problem.

Clearances and approvals by year

Last 15 years

Year	510(k) clearance	De Novo grant	PMA approval	PMA supplement
2026	0	0	0	11
2025	0	0	0	14
2024	0	0	0	12
2023

Newest clearances and approvals

INSPIRE II UPPER AIRWAY STIMULATOR
P130008 · PMA approval · Apr 30, 2014

Newest recalls

Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Pr
Class II · May 11, 2026 · Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a produ
Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire
Class II · May 11, 2026 · Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a produ
Inspire Model 4063 Stimulation Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Class II · Jul 31, 2024 · Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Inspire Model 4340 Respiratory Sensing Lead, component of the Inspire Upper Airway Stimulation (UAS) system.
Class II · Jul 31, 2024 · Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Inspire Model 3028, IV Implantable Pulse Generator
Class I · May 16, 2024 · There is a potential manufacturing defect which can lead to electrical leakage in the sensing circuit which causes a system malfunction and requires a revision

Devices with the most adverse event reports

By product code, all years

Stimulator, Hypoglossal Nerve, Implanted, Apnea (MNQ, class 3)3,491
Graft, Vascular, Stainless Steel Tunneler (MZY, class 2)1

All device makers and procedures · INSP stock page

Official US government data on medical device marketing decisions, recalls (one row per recalled product) and adverse event reports. Company names in the records are linked to INSP with a reviewed list that includes the companies it has bought. Adverse event reports come from makers, hospitals, doctors and patients; a report alone does not prove that a device caused the problem.

Year	Recalls	Class I	Reports	Deaths
2026	2	0	656	-
2025	0	0	958	1
2024	3	1	694	1
2023	0	0	461	1
2022	0	0	283	1
2021	0	0	180	-
2020	0	0	79	-
2019	0	0	91	-
2018	1	0	54	-
2017	0	0	21	-
2016	0	0	11	-
2015	0	0	3	-
2014	0	0	1	-