Inspire 900-001-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10855728005809), received between Oct 14, 2022 and May 13, 2026 — classified as 56 injuries.

The most frequently reported specific device problem is “Migration” (3 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 56 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT RIB AREA NEAR THE SENSING LEAD SITE AND REPORTED SEEING A WIRE BULGING FROM THE RIB CAGE. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, EXPLANTED THE IPG AND SENSE LEAD, IMPLANTED A NEWER IPG MODEL THAT DOES NOT REQUIRE A SENSING LEAD, SUTURED, AND CLOSED.

  Patient problems: Implant Pain

  MAUDE report 25166493 ↗
• InjuryApr 29, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SUSPECTED HYPOGLOSSAL NERVE DAMAGE, INCLUDING ONGOING HEADACHES, DROOLING, VOICE CHANGES, AND TONGUE WEAKNESS. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND EXPLANTED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Headache; Nerve Damage; Neuropathy; Voice alteration

  MAUDE report 25037807 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH CONTINUED RIGHT-SIDED TRAPEZIUS PAIN AND SIGNIFICANT NECK PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND EXPLANTED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Neck Pain

  MAUDE report 24913040 ↗
• InjuryApr 15, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH ONGOING RIGHT-SIDED NECK PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, EXPLANTED THE IPG AND SENSING LEAD, REMOVED A PORTION OF THE STIMULATION LEAD, AND CLOSED. POSTOPERATIVE ANTIBIOTICS WERE PRESCRIBED AFTER THE PROCEDURE WAS COMPLETED.

  Patient problems: Neck Pain

  MAUDE report 24889566 ↗
• InjuryNov 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPON CONCLUSION OF ROOT CAUSE ANALYSIS COMPLETED ON 03 FEB 2026, IT WAS DETERMINED THAT MANUAL MANIPULATION OF THE IMPLANT (TWIDDLER SYNDROME) CONTRIBUTED TO THE ISSUE. THE EXPLANT SURGERY ADDRESSED THE ISSUE AND IS NOW RESOLVED.

  Patient problems: Pain; Twiddlers Syndrome

  MAUDE report 23606250 ↗
• InjuryOct 17, 2025Migration or Expulsion of Device; Migration; Migration or Expulsion of Device; Migration

  PATIENT PRESENTED BACK TO THE PHYSICIAN WITH AN INFECTION AT THE NECK INCISION SITE AND THE STIMULATION LEAD ERODING THROUGH THE SKIN AT THE SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM. PATIENT TO CONTINUE PREVIOUSLY PRESCRIBED ANTIBIOTICS.

  Patient problems: Cyst(s); Erosion; Nodule; Unspecified Infection

  MAUDE report 23328650 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH CHANGES IN VOICE PITCH. PHYSICIAN REFERRED THE PATIENT TO A SPEECH THERAPIST.

  Patient problems: Voice alteration

  MAUDE report 22948874 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH REDNESS AND TENDERNESS AT THE NECK INCISION SITE. AN ALLERGY TEST WAS PERFORMED, SHOWING POSITIVE FOR DERMATITIS AND INFLAMMATORY SKIN CONDITIONS. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND REMOVED THE ENTIRE INSPIRE SYSTEM. PHYSICIAN PRESCRIBED A 10-DAY COURSE OF ANTIBIOTICS POSTOPERATIVELY.

  Patient problems: Contact Dermatitis; Inflammation

  MAUDE report 22740880 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PERSISTENT MIGRAINES. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Headache

  MAUDE report 22256840 ↗
• InjuryJun 17, 2025

  PATIENT PRESENTED TO THE PHYSICIAN WITH AN ONGOING NEUROGENIC COUGH. PHYSICIAN ADMINISTERED A NERVE BLOCK INJECTION TO THE RIGHT LARYNGEAL NERVE. PATIENT RETURNED FOR A FOLLOW-UP APPOINTMENT, SHOWING IMPROVEMENT, AND WILL CONTINUE NERVE BLOCK TREATMENT.

  Patient problems: Cough

  MAUDE report 22244280 ↗
• InjuryMar 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH A PORTION OF THE STIMULATION LEAD BODY ERODED THROUGH THE SKIN AT THE NECK INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Erosion

  MAUDE report 21699443 ↗
• InjuryDec 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH DIFFICULTY SWALLOWING AND BREATHING, THROAT PAIN, AND MARGINAL MANDIBULAR BRANCH WEAKNESS. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REMOVED THE IPG, SENSING LEAD, AND A PORTION OF THE STIMULATION, AND CLOSED.

  Patient problems: Dysphagia/ Odynophagia; Neuropathy; Pain

  MAUDE report 21049123 ↗
• InjuryOct 29, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH NECK PAIN AT THE STIMULATION LEAD SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, PLACED THE STIMULATION LEAD DEEPER, RE-SUTURED, AND CLOSED.

  Patient problems: Neck Pain

  MAUDE report 20557926 ↗
• InjuryOct 8, 2024Material Twisted/Bent; Material Twisted/Bent

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE IPG POCKET. IMAGING WAS PERFORMED WHICH SHOWED EXCESS LEAD BULK BY THE IPG. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND CONFIRMED THE SENSING LEAD AND STIMULATION LEAD WERE TANGLED. PHYSICIAN REPLACED BOTH LEADS AND CLOSED.

  Patient problems: Pain; Twiddlers Syndrome

  MAUDE report 20400691 ↗
• InjuryAug 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SEVERE NECK PAIN. PHYSICIAN ADMINISTERED A ROUND OF CORTISONE SHOTS.

  Patient problems: Neck Pain

  MAUDE report 20075705 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE ER PHYSICIAN WITH THE STIMULATION LEAD ERODED THROUGH THE NECK INCISION. ER PHYSICIAN CLEANED THE AREA AND COVERED THE NECK INCISION. INSPIRE PHYSICIAN BROUGHT THE PATIENT INTO THE OR THE NEXT DAY, OPENED THE NECK INCISION, AND OBSERVED THAT A METAL CLIP POTENTIALLY LEFT IN THE PATIENT WAS STICKING OUT INSTEAD OF THE STIMULATION LEAD. PHYSICIAN REMOVED THE CLIP, FLUSHED THE NECK AREA WITH AN ANTIBIOTIC SOLUTION, TUCKED THE STIMULATION LEAD, AND CLOSED.

  Patient problems: Erosion; Foreign Body In Patient

  MAUDE report 19282174 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SEVERE HEADACHES. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Headache

  MAUDE report 19213796 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SWELLING, DRAINAGE, AND PAIN AT THE NECK INCISION SITE. PHYSICIAN PRESCRIBED MEDICATION. THIS RESOLVED THE ISSUE.

  Patient problems: Fluid Discharge; Pain; Swelling/ Edema

  MAUDE report 19015539 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SEVERE NECK PAIN. PHYSICIAN PRESCRIBED PAIN MEDICATION.

  Patient problems: Neck Pain

  MAUDE report 18838475 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AROUND THE NECK INCISION AREA, PAIN AT THE CHIN, AND LOWER TEETH. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 18769038 ↗
• InjuryDec 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH STIMULATION LEAD WIRE ERODING OUT OF THE SKIN. PHYSICIAN PRESCRIBED ANTIBIOTICS AND CONSULTED WITH PATIENT ABOUT UPCOMING PROCEDURE TO ADDRESS THE STIMULATION LEAD.

  Patient problems: Erosion

  MAUDE report 18292616 ↗
• InjuryDec 1, 2023Impedance Problem; Impedance Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH AN EXPOSED STIMULATION LEAD AT THE NECK INCISION. PHYSICIAN SUSPECTS THE PATIENT HAS BEEN SCRATCHING THE INCISION. PHYSICIAN PRESCRIBED ANTIBIOTICS. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REPLACED THE STIMULATION LEAD.

  Patient problems: Wound Dehiscence

  MAUDE report 18249229 ↗
• InjuryNov 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH THE STIMULATION LEAD BODY EXPOSED AT THE NECK INCISION. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, PERFORMED AN ANTIBIOTIC FLUSH OF THE NECK AREA, AND RESECURED THE STIMULATION LEAD. PHYSICIAN PRESCRIBED ANTIBIOTICS AFTER THE PROCEDURE WAS COMPLETED. AT A FOLLOW-UP APPOINTMENT, PATIENT PRESENTED TO THE PHYSICIAN WITH SWELLING AT THE NECK AND CHEST INCISION SITE. PHYSICIAN PRESCRIBED ADDITIONAL ANTIBIOTICS.

  Patient problems: Erosion; Unspecified Infection

  MAUDE report 18212634 ↗
• InjuryNov 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH THE STIMULATION LEAD EXPOSED THROUGH THE SKIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND RESECURED THE STIMULATION LEAD. PHYSICIAN PRESCRIBED ANTIBIOTICS AFTER THE PROCEDURE WAS COMPLETED. THIS RESOLVED THE ISSUE.

  Patient problems: Erosion

  MAUDE report 18073656 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED BACK TO THE PHYSICIAN WITH THE STIMULATION LEAD PROTRUDING OUT OF THE SKIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, REMOVED THE STIMULATION LEAD, AND PLACED A NEW STIMULATION LEAD.

  Patient problems: Erosion

  MAUDE report 17725780 ↗

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-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-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