Inspire 900-013-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 359 adverse event reports that list this exact device (DI 10855728005793), received between Mar 18, 2025 and Sep 30, 2026 — classified as 358 injuries, 1 malfunction.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (54 reports).

2 FDA recall records name this device's identifier, 2 still open.

2 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.

Recalls naming this device

1. May 11, 2026Class IIOpen, 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 · Recall details · FDA record ↗

2. Jul 31, 2024Class IIOpen, 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 problems

Recent adverse event reports

The 25 most recent of 359 reports, 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 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, 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, 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 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with persistent migraines, as well as pain and tension radiating up the right side of the neck into the temple region. Patient is currently taking medication to manage these symptoms and was referred to a neurologist for further evaluation.

  Patient problems: Headache; Pain

  MAUDE report 50455349 ↗
• InjuryAug 7, 2026Expulsion

  Patient presented to the physician with a portion of the stimulation lead exposed at the neck incision site. Physician brought the patient into the OR, repositioned the stimulation lead deeper beneath the tissue, placed a flex HD graft over the area, re-sutured, and closed.

  Patient problems: Pocket Erosion

  MAUDE report 50178327 ↗
• InjuryAug 4, 2026Expulsion

  Patient presented to the physician with the stimulation lead eroded through the skin at the neck incision site. Physician brought the patient into the OR, irrigated the neck pocket with antibiotic solution, provided additional slack to the stimulation lead, repositioned the lead beneath the tissue, re-sutured, and closed. Postoperative antibiotics were prescribed after the procedure was completed.

  Patient problems: Pocket Erosion

  MAUDE report 50133634 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with significant right-sided throat pain and tenderness upon palpation. Upon examination, the physician was concerned that an infection had developed, contributing to the pain. Physician prescribed pain medication, steroids, and antibiotics, and plans to re-evaluate the patient in three weeks.

  Patient problems: Pain

  MAUDE report 50076893 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with speech difficulties following the implant procedure. The patient attended therapy for treatment after being referred by the physician.

  Patient problems: Speech Disorder

  MAUDE report 50071487 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with persistent infection around the neck incision site, along with pain. Upon examination, redness, swelling, and drainage were noted. Cultures were obtained and returned positive for Staphylococcus aureus infection. Physician prescribed multiple courses of antibiotics to treat the infection.

  Patient problems: Medical device site infection; Pain

  MAUDE report 50059548 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with severe right-sided headaches, neck pain, and right ear pain, along with right-sided tongue weakness, facial paralysis, slurred speech, and difficulty swallowing. Physician prescribed pain medication and steroids.

  Patient problems: Dysphagia/ Odynophagia; Ear Pain; Headache; Neck Pain; Neuropathy; Paralysis; Speech Disorder

  MAUDE report 50058963 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with persistent neck pain since the implant procedure. Physician brought the patient into the OR and explanted the entire Inspire system.

  Patient problems: Neck Pain

  MAUDE report 50058430 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with persistent symptoms of tongue weakness and difficulty with speech. Physician referred the patient to speech therapy, and the patient has been attending speech therapy for treatment. Patient presented back to the physician with no improvement in symptoms. Physician will monitor the patient and further evaluate.

  Patient problems: Neuropathy; Speech Disorder

  MAUDE report 50011843 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  After the implant procedure was completed, while recovering in the PACU, the patient developed bleeding and drainage from the neck incision site. Physician attempted to achieve hemostasis by applying pressure but was unsuccessful. Physician brought the patient back into the OR, intubated the patient, achieved hemostasis using cautery, and closed the incision. This resolved the issue.

  Patient problems: Fluid Discharge; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50011683 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with redness and drainage at the neck incision site. Cultures were obtained, and the results were positive for infection. Physician prescribed multiple courses of antibiotics and referred the patient to an infectious disease specialist for further evaluation.

  Patient problems: Medical device site infection

  MAUDE report 50009294 ↗
• InjuryJun 30, 2026Expulsion

  PATIENT PRESENTED TO THE PHYSICIAN WITH THE STIMULATION LEAD ERODED THROUGH THE SKIN AT THE NECK INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, IRRIGATED THE NECK POCKET WITH BETADINE AND SALINE, REPOSITIONED THE STIMULATION LEAD BENEATH THE TISSUE, RE-SUTURED, AND CLOSED.

  Patient problems: Pocket Erosion

  MAUDE report 25662237 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH AN INFECTION AT THE NECK INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, ADMINISTERED PREOPERATIVE IV ANTIBIOTICS, AND EXPLANTED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Medical device site infection

  MAUDE report 25638167 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH THE STIMULATION LEAD MIGRATING TOWARD THE NECK INCISION SITE, POSING A RISK OF EROSION. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, REPOSITIONED THE STIMULATION LEAD DEEPER BENEATH THE TISSUE, RE-SUTURED, APPLIED A COLLAGEN PATCH, AND CLOSED. THE REVISION SURGERY ADDRESSED THE RISK, AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637823 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH ONGOING SEVERE EAR PAIN AND PAIN AT THE IMPLANT SITE TRIGGERED BY MOVEMENT. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, EXPLANTED THE IPG, REMOVED A PORTION OF THE STIMULATION LEAD, AND CLOSED.

  Patient problems: Ear Pain; Implant Pain

  MAUDE report 25636715 ↗

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-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