Inspire 900-001-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10855728005670), received between Nov 28, 2022 and May 26, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Expulsion” (1 report).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH AN ONGOING LISP. PATIENT WAS REFERRED TO AND ATTENDED SPEECH THERAPY WITHOUT RESOLUTION. PATIENT ALSO REPORTED THAT THEY HAVE NOW DEVELOPED SALIVA BUILDUP.

  Patient problems: Salivary Hypersecretion; Speech Disorder

  MAUDE report 25281127 ↗
• InjuryApr 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 OPERATING ROOM AND EXPLANTED THE ENTIRE INSPIRE SYSTEM. POSTOPERATIVE ANTIBIOTICS WERE PRESCRIBED AFTER THE PROCEDURE WAS COMPLETED.

  Patient problems: Erosion

  MAUDE report 25053578 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SWELLING AND PAIN IN THE NECK AREA WHEN USING THERAPY. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, REMOVED THE IPG, SENSING LEAD, AND A PORTION OF THE STIMULATION LEAD, AND CLOSED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 23840344 ↗
• InjuryJul 15, 2025Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SWELLING AT THE CHEST INCISION SITE. UPON ASPIRATION, PURULENT FLUID WAS NOTED. DUE TO POTENTIAL INFECTION, THE PHYSICIAN PRESCRIBED A 14-DAY COURSE OF ANTIBIOTICS.

  Patient problems: Erosion; Purulent Discharge; Unspecified Infection

  MAUDE report 22509586 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH A SHOCKING SENSATION AND PAIN ON THE TONGUE WHEN USING THERAPY. PHYSICIAN PRESCRIBED PAIN MEDICATION.

  Patient problems: Pain

  MAUDE report 21667214 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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, REMOVED A PORTION OF THE STIMULATION LEAD AND THE IPG, AND CLOSED.

  Patient problems: Erosion

  MAUDE report 21644659 ↗
• InjuryMar 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH EROSION OF THE STIMULATION LEAD AT THE NECK INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, TUCKED THE STIMULATION LEAD DEEPER, AND CLOSED.

  Patient problems: Erosion

  MAUDE report 21619094 ↗
• InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH A FLUID FILLED LUMP AT THE NECK INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, OPENED THE NECK INCISION SITE, AND DISCOVERED A LARGE MASS WITH SIGNS OF INFECTION. PHYSICIAN REMOVED THE MASS AND DECIDED TO REMOVE THE ENTIRE INSPIRE SYSTEM. PHYSICIAN PRESCRIBED ANTIBIOTICS AFTER THE PROCEDURE WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 20158461 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH INTENSE PAIN AROUND THE SIMULATION LEAD SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 19907792 ↗
• InjuryOct 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SWELLING AND POTENTIAL INFECTION AT THE NECK INCISION. PHYSICIAN PRESCRIBED ANTIBIOTICS. THIS RESOLVED THE ISSUE.

  Patient problems: Swelling/ Edema

  MAUDE report 18032500 ↗
• InjuryJul 10, 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 STICKING OUT OF THE NECK AFTER PICKING AT A SCAB. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, TUCKED THE STIMULATION LEAD BACK INTO PLACE, AND CLOSED.

  Patient problems: Erosion

  MAUDE report 17293686 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT DEVELOPED A HEMATOMA AT THE STIMULATION LEAD SITE POST-IMPLANT PROCEDURE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR TO EVACUATE THE HEMATOMA AND PLACED A DRAIN.

  Patient problems: Hematoma

  MAUDE report 15869198 ↗

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