Facility

INSPIRE MEDICAL SYSTEMS INC

4 recall(s) on record — most severe on record: Class I.

Key facts

4recalls · worst Class I

3inspections · worst VAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007666314
Establishment type	Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility; Manufacture Medical Device
Location	5500 Wayzata Blvd. Suite 1600 Golden Valley, MN, US 55416
Registration status	Active · expires 2026
Parent company	Inspire Medical Systems Inc. (owner-operator 10046749)
Brand names	Model 2740 Physician Programmer; Model 4063 Stimulation Lead; Model 2500 Sleep Remote; Model 3032 Sleep Remote; Model 3028 MR Conditional Implantable Pulse Generator; Model 3024 Implantable Pulse Generator; Model 4323 Sensing Lead; Model 4340 Sensing Lead; Model 2580 Sleep Remote; SleepSync Model 2740S Inspire Programming Software Application; Model 3150 MR Conditional Implantable Pulse Generator; SleepSync Model 2740C Inspire Programmer Cable

Activity by year

Recalls (4)
Inspections (3)

Devices registered here (1)

Stimulator, Hypoglossal Nerve, Implanted, Apnea
Product code MNQ (opens in a new tab) · Class III · Unknown

Recalls & enforcement

Class IIOngoing2026-05-11
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer. Material degradation of a product past its Use By Date may result in unplanned or premature revision surgery.
Class IIOngoing2024-07-31
Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.
Class IOngoing2024-05-16
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 surgery to replace the IPG,
Class IITerminated2018-06-12
Incorrect use-by date on the device registration/patient file labels.

FDA inspections (3)

VAI2024-05-10
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
NAI2021-09-16
No Action Indicated · Compliance: Devices
VAI2018-06-22
Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “INSPIRE MEDICAL SYSTEMS INC (FEI 3007666314) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007666314-inspire-medical-systems-inc/

Not open yet

Alerts for INSPIRE MEDICAL SYSTEMS INC

Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.

Planned

Want a one-page facility brief?

A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.