Inspire 900-007-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 248 adverse event reports that list this exact device (DI 10855728005656), received between Sep 16, 2019 and Jul 27, 2026 — classified as 1 death, 247 injuries.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (15 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 248 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with pain at the IPG site, including pain radiating from the IPG site to the armpit region when lifting heavy objects. Physician prescribed steroids.

  Patient problems: Implant Pain

  MAUDE report 50011424 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE IPG SITE. PHYSICIAN PRESCRIBED AN ANTI-INFLAMMATORY MEDICATION.

  Patient problems: Implant Pain

  MAUDE report 25462811 ↗
• InjuryMay 5, 2026Expulsion

  PATIENT PRESENTED TO THE PHYSICIAN WITH WOUND DEHISCENCE AT THE CHEST INCISION SITE, AND THE IPG HAD ERODED THROUGH THE SKIN. ON EXAMINATION, THE PHYSICIAN NOTED REDNESS, SWELLING, AND YELLOW FLUID AT THE SITE. PHYSICIAN CLEANED THE AREA WITH BETADINE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR SEVEN DAYS LATER, EXPLANTED THE IPG AND SENSING LEAD, AND A PORTION OF THE STIMULATION, AND CLOSED.

  Patient problems: Inflammation; Pocket Erosion; Wound Dehiscence

  MAUDE report 25086599 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE IPG SITE AND INABILITY TO SLEEP WITH THERAPY. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND EXPLANTED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 24654176 ↗
• InjuryFeb 6, 2026Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH THE IPG MOVING WITHIN THE POCKET, CAUSING PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REMOVED THE IPG AND SENSING LEAD, IMPLANTED A NEWER IPG MODEL, WHICH DOES NOT REQUIRE A SENSING LEAD, SUTURED, AND CLOSED.

  Patient problems: Pain

  MAUDE report 24283469 ↗
• InjuryAug 20, 2025Adverse 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. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REMOVED THE IPG, SENSING LEAD, AND A PORTION OF THE STIMULATION LEAD BODY, AND CLOSED.

  Patient problems: Pain

  MAUDE report 22849781 ↗
• InjuryNov 21, 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 NECK AND THE IPG SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REPLACED THE ENTIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 20750774 ↗
• InjuryNov 11, 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 REACHING FOR SOMETHING IN THEIR VEHICLE. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND REPLACED THE IPG AND SENSING LEAD.

  Patient problems: Pain

  MAUDE report 20652215 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH AN INFECTION AT THE CHEST INCISION SITE. PHYSICIAN PRESCRIBED ANTIBIOTICS. PHYSICIAN BROUGHT THE PATIENT INTO THE OR 6 DAYS LATER AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 20577063 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SCAR PAIN AT THE CHEST INCISION SITE. PHYSICIAN GAVE PATIENT STEROID INJECTIONS. THIS RESOLVED THE ISSUE.

  Patient problems: Pain

  MAUDE report 19111198 ↗
• InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH EXCORIATIONS AT THE IPG CHEST INCISION. PHYSICIAN PRESCRIBED ANTIBIOTICS.

  Patient problems: Erythema; Skin Inflammation/ Irritation

  MAUDE report 18923891 ↗
• InjuryFeb 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH CHEST PAIN AT THE IPG SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 18652595 ↗
• InjuryJan 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN RADIATING IN THE CHEST AROUND THE IPG SITE WHEN USING INSPIRE THERAPY. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND REPLACED THE SENSING LEAD AND IPG. THIS RESOLVED THE ISSUE.

  Patient problems: Pain

  MAUDE report 18546182 ↗
• InjuryOct 30, 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. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REPOSITIONED THE IPG AND LEADS, SUTURED THE DEVICE, AND CLOSED THE CHEST INCISION.

  Patient problems: Pain

  MAUDE report 18031055 ↗
• InjurySep 12, 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. PHYSICIAN IS UNABLE TO DETERMINE WHAT IS CAUSING THE PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND REMOVED THE INSPIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 17728655 ↗
• InjuryJul 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH INFECTION AT THE IPG SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 17385471 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE INSPIRE IMPLANT PROCEDURE, THE PATIENT DEVELOPED A PNEUMOTHORAX AND REQUIRED 2% OXYGEN TO MAINTAIN SAT LEVEL ABOVE 90. PHYSICIAN CONSULTED WITH RADIOLOGIST AND PIGTAIL CATHETER WAS PLACED WITH GUIDANCE OF CT FLUOROSCOPY. PATIENT TO BE KEPT OVERNIGHT. THIS RESOLVED THE ISSUE.

  Patient problems: Pneumothorax

  MAUDE report 15609439 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH REDNESS, TENDERNESS, AND EXPOSED IPG. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE INSPIRE SYSTEM AND FLUSHED THE AREA. THIS RESOLVED THE ISSUE.

  Patient problems: Erosion

  MAUDE report 15607012 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH EAR PAIN. PHYSICIAN PRESCRIBED STEROIDS AND ANTIBIOTICS. THIS RESOLVED THE ISSUE.

  Patient problems: Pain

  MAUDE report 15579723 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH MILD REDNESS AND WEEPING FROM THE CHEST WALL INCISION. PHYSICIAN PRESCRIBED A COURSE OF ORAL ANTIBIOTICS AND TOPICAL MUPIROCIN CREAM. PATIENT PRESENTED BACK TO THE PHYSICIAN WITH REDNESS AND IMPROVED WEEPING FROM THE CHEST WALL SITE AND REDNESS ON HIS CHIN LINE INCISION. PHYSICIAN BELIEVES IT IS THE SUTURE TRYING TO EXTRUDE AND INJECTED BOTH SITES WITH A STEROID. PATIENT PRESENTED BACK AGAIN TO THE PHYSICIAN WITH SWELLING AND INCREASED PAIN UNDER THE CHIN. PHYSICIAN PRESCRIBED ANTIBIOTICS, ORAL STEROIDS, AND ORAL BENADRYL.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15574454 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH A HEMATOMA 8 DAYS POST IMPLANT PROCEDURE. PATIENT WAS ON A BLOOD THINNER DURING THE PROCEDURE BUT DISCONTINUED ONCE THE HEMATOMA DEVELOPED. PATIENT KEPT OVERNIGHT. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND OBSERVED SUPERFICIAL BLEEDING AND BLOOD CLOTS. PHYSICIAN CLEANED THE POCKET, REMOVED THE IPG, AND DID ADDITIONAL CLEANING OF THE POCKET. PHYSICIAN USED BIPOLAR ENERGY AND ANTICOAGULANT POWDER TO STOP THE BLEEDING. HEMATOMA WAS EVACUATED. IPG WAS PLACED BACK INTO THE POCKET AND RE-SUTURED. THIS RESOLVED THE ISSUE.

  Patient problems: Hematoma

  MAUDE report 15534329 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH AN INFECTION WITH BACTERIA. PHYSICIAN PRESCRIBED ANTIBIOTICS AND BROUGHT THE PATIENT INTO THE OR 8 DAYS LATER AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Bacterial Infection

  MAUDE report 15532210 ↗
• InjurySep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH A RED IPG SITE WITH SUSPECTED INFECTION. PHYSICIAN PRESCRIBED ANTIBIOTICS FOR 10 DAYS. THIS RESOLVED THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 15489406 ↗
• InjurySep 24, 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 IPG IMPLANT SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE IPG.

  Patient problems: Pain

  MAUDE report 15477953 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AND SWELLING ON THE RIGHT SIDE OF THE CHEST. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED A MAJORITY OF THE INSPIRE SYSTEM. THE SENSING LEAD WAS CUT NEAR THE IPG AND THE DISTAL END REMAINS.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15477117 ↗

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