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Inspire 900-009-001Recalls & reported problems

Inspire Medical Systems, Inc. · The sensing lead incorporates a differential pressure sensor that detects respiratory cycles. The connector end of the lead is connected to the IPG. The sensor is implanted in between the intercostal muscle layers. The device senses relative pressure variations that correspond to the respiration cycle. The pressure waveform is monitored by the IPG and triggers stimulation therapy synchronous with inspiration · Class 3 · Implant

All models of Inspire Sleep Apnea Implant (24)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10855728005458), received between Feb 13, 2019 and Aug 29, 2019 — classified as 2 injuries.

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 16, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem2

Patient problems

  • Skin Irritation1
  • Wound Dehiscence1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    PATIENT WAS SEEN BY IMPLANTING PHYSICIAN. THE SENSE INCISION WAS OPEN, BUT IT WAS NOT INFECTED. THE SKIN EDGES ARE 2-3 MM APART FOR APPROXIMATELY 2/3 OF WOUND. MUPIROCIN AND STERI-STRIPS WERE APPLIED. ORAL ANTIBIOTIC WERE PRESCRIBED. THE ISSUE WAS RESOLVED AS OF (B)(6) 2019 AND THE PATIENT WAS ACTIVATED.

    Patient problems: Wound Dehiscence

    MAUDE report 8946466 ↗
  • InjuryFeb 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    THE PATIENT PRESENTED TO THE PHYSICIAN'S OFFICE FOR SURGICAL FOLLOW UP WITH A RASH AT SENSE LEAD INCISION SITE. PATIENT REPORTS RASH BEGAN ON (B)(6) 2019. CONSULTATION WITH DERMATOLOGIST SUGGESTS CLASSIC CONTACT DERMATITIS FROM EITHER BETADINE OR IOBAN.

    Patient problems: Skin Irritation

    MAUDE report 8337375 ↗

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

Other Stimulator, Hypoglossal Nerve, Implanted, Apnea devices

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Sources and updates

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