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Inspire 900-004-001Recalls & reported problems

Inspire Medical Systems, Inc. · The Model 2740 physician programmer is designed for use by a physician to non-invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short-range radio-frequency (RF) telemetry; telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. This data can also be printed via a wireless Bluetooth link to a commercial printer. · Class 3 · Implant

All models of Inspire Sleep Apnea Implant (24)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00855728005055), received between Aug 11, 2017 and Aug 11, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (1 report).

3 other recalls cover devices cleared under the same FDA submission (P130008); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Device Operates Differently Than Expected1

Patient problems

  • Discomfort1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 11, 2017Device Operates Differently Than Expected

    PATIENT HAS HAD DIFFICULTY WITH SWALLOWING AND SPEAKING. DEVICE WAS NOT USED FOR A PERIOD OF TIME TO ALLOW THE PATIENT TO HEAL FROM IMPLANT. ISSUES RESOLVED FOR A TIME BUT THEN RETURNED A WHILE AFTER THE DEVICE WAS REACTIVATED. PHYSICIAN IS HAVING THE PATIENT LEAVE THE DEVICE OFF FOR NOW TO ALLOW THE PATIENT MORE TIME TO HEAL FROM IMPLANT.

    Patient problems: Discomfort

    MAUDE report 6790029 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P130008. One submission often covers many models, so check the product and lot details in each record.

  • Z-2516-2026 · May 11, 2026 · Open, Classified
    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire stimulation Lead Model/Catalog Number: 4063 Product Description: The Inspire Stimulation Lead (Model 4063) is design
  • Z-2515-2026 · May 11, 2026 · Open, Classified
    Brand Name: Inspire Medical Systems, Inc. Product Name: Inspire Respiratory Sensing Lead Model/Catalog Number: 4340 Software Version: N/A Product Description: The Inspire Respirato
  • Z-2969-2018 · Jun 12, 2018 · Terminated
    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 Inspir

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Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page