Inspire Sleep Apnea ImplantRecalls & reported problems across all models

We found 24 models of Inspire Sleep Apnea Implant by Inspire Medical Systems, Inc. in the FDA's device registry (GUDID). Together they are named in 2,200 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2016 and Sep 30, 2026 — classified as 4 deaths, 2,093 injuries, 103 malfunctions.

The most frequently reported specific device problem is “Migration” (141 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Inspire Sleep Apnea Implant recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 11, 2026Open, Classified

   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.

   Z-2516-2026 · Root cause: Process control · names 2 of these models · Recall details · FDA record ↗

2. May 11, 2026Open, Classified

   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.

   Z-2515-2026 · Root cause: Process control · Recall details · FDA record ↗

3. Jul 31, 2024Open, Classified

   Labeling error with a mismatch between the shelf box serial number label and the serial number of the lead provided in the box.

   Z-0041-2025 · Root cause: Process control · Recall details · FDA record ↗

Most reported Inspire Sleep Apnea Implant problems

Inspire Sleep Apnea Implant models

24 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Inspire 900-007-014

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  3 deaths1,012 reports
• Inspire 900-013-001

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  2 recalls359 reports
• Inspire 900-007-008

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  1 death248 reports
• Inspire 900-009-002

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  138 reports
• Inspire 900-001-009

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  125 reports
• Inspire 900-001-011

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  56 reports
• Inspire 900-013-003

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  1 recall0 reports
• Inspire 900-014-005

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  1 recall0 reports
• Inspire 900-007-003

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  46 reports
• Inspire 900-003-015

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  45 reports
• Inspire 900-009-003

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  43 reports
• Inspire 900-001-008

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  26 reports
• Inspire 900-002-005

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  17 reports
• Inspire 900-001-005

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  13 reports
• Inspire 900-002-007

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  12 reports
• Inspire 900-001-010

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  12 reports
• Inspire 900-002-010

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  10 reports
• Inspire 900-007-001

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  9 reports
• Inspire 900-002-008

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  9 reports
• Inspire 900-007-010

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  8 reports
• Inspire 900-002-009

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  5 reports
• Inspire 900-001-007

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  4 reports
• Inspire 900-009-001

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  2 reports
• Inspire 900-004-001

  Stimulator, Hypoglossal Nerve, Implanted, Apnea
  1 report

Recent Inspire Sleep Apnea Implant adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with pain at the chin and neck. Due to these persistent symptoms, the patient requested removal of the device. Physician brought the patient into the OR and explanted the entire Inspire system.

  Patient problems: Neck Pain; Pain

  MAUDE report 50950137 ↗
• InjurySep 30, 2026Expulsion

  Patient problems: Pocket Erosion

  MAUDE report 50949988 ↗
• InjurySep 30, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949709 ↗
• InjurySep 30, 2026Migration

  Patient presented to the physician with movement of the IPG within the pocket, causing pain. Imaging was obtained, showing that the IPG appeared to have shifted downward. Physician brought the patient into the OR, re-sutured the IPG securely, and closed.

  Patient problems: Pain

  MAUDE report 50949538 ↗
• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with ongoing right-sided tongue paralysis and left-sided tongue deviation. Upon examination, the physician confirmed nerve damage attributed to Inspire. No intervention has been reported at this time. Physician plans to re-evaluate the patient.

  Patient problems: Nerve Damage; Neuropathy

  MAUDE report 50936369 ↗
• InjurySep 17, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Medical device site infection

  MAUDE report 50809535 ↗
• InjurySep 2, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Nerve Damage; Neuropathy; Speech Disorder

  MAUDE report 50568227 ↗
• InjurySep 1, 2026Expulsion

  Patient presented to the physician on (b)(6) 2026 with the stimulation lead eroded through the skin at the neck incision site. No intervention was performed at the time. On (b)(6) 2026, the physician brought the patient into the Operating Room, repositioned the lead beneath the tissue, re-sutured, and closed the incision.

  Patient problems: Pocket Erosion

  MAUDE report 50549250 ↗
• InjuryAug 27, 2026Migration

  Patient presented to the physician with flipping and movement of the IPG within the pocket, resulting in pain. Physician brought the patient into the OR, re-sutured the IPG, and closed.

  Patient problems: Pain

  MAUDE report 50484048 ↗
• InjuryAug 27, 2026Expulsion

  Patient presented to the physician with the stimulation lead eroded through the skin at the neck incision site and also reported headaches. Physician noted that the patient had been taking antibiotics and steroids. Physician brought the patient into the OR, repositioned the lead beneath the tissue, irrigated the site with antibiotic solution, re-sutured, and closed.

  Patient problems: Headache; Pocket Erosion

  MAUDE report 50482845 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician, post-implant procedure, with a hematoma at the neck incision site. Physician brought the patient into the OPERATING ROOM, drained the hematoma, irrigated the neck pocket, and closed.

  Patient problems: Hematoma

  MAUDE report 50464517 ↗
• InjuryAug 26, 2026Impedance Problem

  During a routine follow-up appointment, the physician identified a device impedance issue. Imaging was obtained, which indicated a possible stimulation lead issue. Physician brought the patient to the operating room, and upon surgical exploration, the stimulation lead was found to be damaged. The physician noted twiddler syndrome, which posed a risk of patient injury. Physician explanted the existing stimulation lead, implanted a new lead, sutured, and closed. The revision surgery restored therapy, addressed the risk, and the issue is now resolved.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50464499 ↗
• InjuryAug 26, 2026Migration

  Patient presented to the physician with flipping of the IPG within the pocket, posing a potential risk of injury. Physician brought the patient into the OR, and upon surgical exploration, twiddling of the device was noted. Physician explanted the IPG, sensing lead, and a portion of the stimulation lead, and closed. The explant surgery addressed the risk, and the issue is now resolved.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50458208 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with a burning and stabbing sensation at the chest incision site. Physician brought the patient into the OR, explanted the IPG and sensing lead, implanted a newer IPG model that does not require a sensing lead, connected the new IPG to the existing stimulation lead, sutured, and closed.

  Patient problems: Burning Sensation

  MAUDE report 50457460 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with persistent headaches. Physician prescribed medication to manage the symptoms.

  Patient problems: Headache

  MAUDE report 50455575 ↗