Inspire 900-003-015Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00855728005024), received between Jun 9, 2016 and Nov 11, 2025 — classified as 41 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (4 reports).

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

Recent adverse event reports

The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH INTERMITTENT SHOCKING SENSATIONS AND PAIN AT THE IPG SITE. PHYSICIAN BROUGHT THE PATIENT TO THE OR, REMOVED THE IPG, IMPLANTED A NEWER IPG MODEL, SUTURED, AND CLOSED. THE EXISTING SENSING LEAD WAS ABANDONED AS IT IS NOT USED WITH THE NEW IPG MODEL.

  Patient problems: Pain

  MAUDE report 23524205 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN REQUESTING AN UPGRADE TO A NEWER MRI-COMPATIBLE IPG AND ALSO REPORTED CHEST PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REPLACED THE IPG, AND CLOSED.

  Patient problems: Pain

  MAUDE report 23426610 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FOLLOWING A FALL, THE PATIENT PRESENTED TO THE PHYSICIAN WITH REDNESS AND SWELLING AT THE IPG SITE. PHYSICAL EXAMINATION REVEALED SIGNS OF INFECTION. THE PHYSICIAN PRESCRIBED ANTIBIOTICS. THE PATIENT RETURNED WITH PERSISTENT INFECTION AND PURULENT DRAINAGE FROM THE INCISION SITE. THE CHEST INCISION WAS DRAINED. THE NEXT DAY, THE PATIENT WAS TAKEN TO THE OR WHERE THE IPG WAS REMOVED, THE LEADS WERE CAPPED, AND THE INCISION SITE WAS CLOSED. POSTOPERATIVE ANTIBIOTICS WERE PRESCRIBED.

  Patient problems: Purulent Discharge; Unspecified Infection

  MAUDE report 21944977 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE IPG SITE AFTER UNDERGOING AN IMAGING PROCEDURE. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND DECIDED TO REPLACE THE IPG AS IT WAS AN OLDER MODEL. PHYSICIAN OPENED THE INCISION, REPLACED THE IPG, RE-POSITIONED IPG RELATIVE TO ORIGINAL IMPLANT, AND CLOSED.

  Patient problems: Pain

  MAUDE report 18838119 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SYSTEMIC MRSA INFECTION. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 18096922 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE IPG SITE WHEN LAYING ON THE RIGHT SIDE AND THINNING AREA OF THE TISSUE NEAR THE IPG INCISION. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, EXCISED THE AREA OF SCAR THAT HAD THINNED, REMOVED SOME SCAR TISSUE, AND PLACED THE NEW IPG IN THE SAME POCKET. THIS RESOLVED THE ISSUE.

  Patient problems: Pain

  MAUDE report 16888886 ↗
• InjuryMay 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED IPG EXPOSED AT THE CHEST INCISION SITE 5 MONTHS POST COMPLETION OF CHEMOTHERAPY FOR BREAST CANCER. PHYSICIAN PLACED THE PATIENT ON ANTIBIOTICS AND BROUGHT THE PATIENT INTO THE OR 1 WEEK LATER AND REMOVED THE ENTIRE SYSTEM.

  Patient problems: Erosion

  MAUDE report 14342981 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED TO THE PHYSICIAN THAT THE IPG HAS BEEN MOVING MOBILE AND WAS CAUSING PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND REPLACED THE IPG. THIS RESOLVED THE ISSUE.

  Patient problems: Pain

  MAUDE report 13548633 ↗
• InjuryFeb 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE SENSE LEAD SITE, REPORTED A LACK OF EFFICACY, AND REQUESTED REMOVAL OF INSPIRE SYSTEM. PHYSICIAN REMOVED THE INSPIRE SYSTEM. THIS RESOLVED THE ISSUE.

  Patient problems: Pain

  MAUDE report 13548567 ↗
• InjuryOct 14, 2021Unintended Electrical Shock; Unintended Electrical Shock

  PATIENT UNDERWENT CONTRAINDICATED MRI SCAN OF THE LOWER BACK. DURING THE SCAN, THE PATIENT EXPERIENCED INTENSE BURNING STIMULATION IN HIS NECK, CHEST, AND EAR. IMMEDIATELY FOLLOWING THE SCAN, PATIENT REPORTS THAT THEY WERE STILL EXPERIENCING PAIN IN THE THROAT, CHEST, AND EAR AS WELL AS A HEADACHE. THE MRI MACHINE WAS ON FOR LESS THAN ONE MINUTE AND THE DOCTOR CONFIRMED NO TISSUE DAMAGE TOOK PLACE FROM THE EVENT.

  Patient problems: Pain

  MAUDE report 12633214 ↗
• InjuryFeb 23, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT PRESENTED TO THE PHYSICIAN WITH THINNING SKIN OVER THE IPG. PHYSICIAN SURGICALLY REPLACED THE DEVICE AND RESOLVED THE PATIENT¿S ISSUE.

  Patient problems: Erosion

  MAUDE report 11366080 ↗
• InjurySep 21, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT PRESENTED TO PHYSICIAN WITH PAIN AND THINNING OF THE SKIN AT THE IPG SITE. SURGEON REPLACED THE IPG ON (B)(6) 2020 TO ADDRESS PATIENT''S PAIN AS WELL AS TO ADDRESS FUTURE MRI NEEDS.

  Patient problems: Pain

  MAUDE report 10563387 ↗
• InjuryJul 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED PAIN AT THE IPG SITE. THE PHYSICIAN DETERMINED THAT THE IPG WAS SUPERFICIAL AND DECIDED TO REPLACE IT WITH THE SMALLER IPG (MODEL 3028) ON (B)(6) 2020.

  Patient problems: Erosion

  MAUDE report 10258382 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED INTERMITTENT SENSE LEAD PAIN SYMPTOMATIC OF INTERCOSTAL NEURALGIA. THE SURGEON REMOVED THE INSPIRE SYSTEM (B)(6) 2019.

  Patient problems: Pain

  MAUDE report 9467624 ↗
• InjurySep 30, 2019Migration; Migration

  THE PHYSICIAN FOUND VIA X-RAY THAT THE IPG HAS MIGRATED DOWNWARD. THE PHYSICIAN PERFORMED REVISION SURGERY ON (B)(6) 2019 TO RE-SECURE THE IPG WITH SUTURES. ISSUE IS NOW RESOLVED WITHOUT COMPLICATIONS.

  Patient problems: Erosion

  MAUDE report 9135549 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ANTIBIOTICS (DICLOXACILLIN) PRESCRIBED TO TREAT SWELLING AT THE SITE OF THE INCISION.

  Patient problems: Cellulitis

  MAUDE report 8782611 ↗
• InjuryJul 9, 2019Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  DURING A REVISION SURGERY TO RESTORE THERAPY, THE SURGEON FOUND EXTENSIVE DAMAGE TO BOTH LEADS DUE TO TWIDDLER'S SYNDROME. THE STIMULATION LEAD WAS FOUND FRACTURED IN THE RIGHT SUBLINGUAL REGION NEAR THE SUBMANDIBULAR GLAND. THE REMAINDER OF THE STIMULATION LEAD RETRACTED INTO THE CHEST WALL AND COILED IN THE AREA OF THE BATTERY PACK. THE SENSING LEAD WAS ALSO DAMAGED.

  Patient problems: Twiddlers Syndrome

  MAUDE report 8773740 ↗
• InjuryJul 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT DEVELOPED VERY MILD ERYTHEMA OVER THE IPG SITE NOTED ON THE POST-OP VISIT AND WAS STARTED ON AN ANTIBIOTIC. IT COMPLETELY RESOLVED, UNEVENTFULLY ON FOLLOW UP VISIT. DATE OF EVENT UNKNOWN.

  Patient problems: Erythema

  MAUDE report 8772068 ↗
• InjuryJun 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DATE OF EVENT START IS UNKNOWN; ASSOCIATED STUDY VISIT (B)(6) 2017. PATIENT WAS ADMITTED TO THE HOSPITAL WITHIN ONE MONTH OF IMPLANT FOR THE TREATMENT OF NECK SWELLING, EPISODES OF DIZZINESS, SWEATING, AND SEEING SPOTS. ADVERSE EVENT RESOLVED BY (B)(6) 2017.

  Patient problems: Dizziness

  MAUDE report 8723049 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT COMPLAINED OF A LISP WITH NO NERVE WEAKNESS 3 MONTHS AFTER IMPLANT. THE PHYSICIAN REPORTED THAT THIS RESOLVED WITHOUT INTERVENTION.

  Patient problems: Dysphasia

  MAUDE report 8717365 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT COMPLAINED OF LISPING, RIGHT LOWER LIP NUMBNESS, AND A CROOKED SMILE AT HIS POST-OP, 1-MONTH, AND 2-MONTH APPOINTMENTS. THE PHYSICIAN CONFIRMED THAT THE ISSUE IS NOW RESOLVED.

  Patient problems: Dysphasia; Facial Nerve Paralysis

  MAUDE report 8693651 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CHEST SEROMA. THE PATIENT HAD BEEN DOING SOME HEAVY LIFTING AFTER IMPLANT AND THE SEROMA RESULTED. THE SURGEON, DR. (B)(6), EVACUATED THE SEROMA IN OFFICE AND SENT THE PATIENT HOME. THE PHYSICIAN CONFIRMED THAT THE SEROMA WAS RESOLVED.

  Patient problems: Seroma

  MAUDE report 8693322 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT CHEST SEROMA AT 5 WEEKS POST-OP. ISSUE REPORTED AS RESOLVED BY THE PHYSICIAN.

  Patient problems: Seroma

  MAUDE report 8693296 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SLURRED SPEECH WAS REPORTED AT THE POST-TITRATION VISIT AND FINAL VISIT (1 YEAR APART). THE PHYSICIAN CONFIRMS THAT SLURRED SPEECH ISSUES HAVE RESOLVED.

  Patient problems: Dysphasia

  MAUDE report 8689388 ↗
• InjuryJun 11, 2019Migration; Migration

  THE ANCHOR OF THE STIMULATION LEAD WAS NOTED TO HAVE MIGRATED. THE SURGEON REPOSITIONED THE ANCHOR IN A REVISION SURGERY WHICH RESOLVED THE ISSUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8689312 ↗

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