Inspire 900-009-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10855728005892), received between Oct 25, 2022 and Apr 20, 2026 — classified as 19 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (14 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryApr 20, 2026Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN FROM THE BACK RADIATING TO THE IPG SITE. IMAGING WAS PERFORMED, REVEALING THAT THE SENSING LEAD HAD MIGRATED. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, EXPLANTED THE IPG AND SENSE LEAD, IMPLANTED A NEWER IPG MODEL THAT DOES NOT REQUIRE A SENSING LEAD, SUTURED, AND CLOSED.

  Patient problems: Back pain; Implant Pain

  MAUDE report 24927415 ↗
• InjuryApr 8, 2026Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH CHEST PAIN AND PAIN AT THE SENSING LEAD PLACEMENT SITE WHEN BREATHING. IMAGING WAS PERFORMED, REVEALING THAT THE SENSING LEAD HAD PROJECTED INTO THE PLEURAL SPACE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, AND UPON SURGICAL EXPLORATION, IT WAS CONFIRMED THAT THE SENSOR TIP HAD MIGRATED TOWARD THE PLEURAL SPACE. PHYSICIAN REPOSITIONED THE SENSE LEAD, SUTURED, AND CLOSED.

  Patient problems: Pain

  MAUDE report 24824465 ↗
• MalfunctionFeb 20, 2026Corroded; Device Sensing Problem; Material Split, Cut or Torn

  DURING A SYSTEM CHECK PERFORMED AT A ROUTINE CLINIC VISIT, THE PHYSICIAN OBSERVED A SENSING ISSUE. PHYSICIAN BROUGHT THE PATIENT IN FOR SURGICAL INTERVENTION AND OBSERVED CORROSION AT THE IPG HEADER SENSE LEAD PIN CONNECTOR PORT AND AT THE SENSING LEAD CONNECTOR PIN. PHYSICIAN ATTEMPTED TO CLEAN THE CORROSION, AND THE CONNECTOR PIN DETACHED. PHYSICIAN EXPLANTED THE IPG AND SENSING LEAD AND IMPLANTED A NEW IPG AND SENSING LEAD, AND THE INCISION WAS CLOSED. UPON CONCLUSION OF ROOT CAUSE INVESTIGATION AND RETURNED PRODUCT ANALYSIS ON 5 FEB 2026, WE FOUND THAT THE IPG GROMMET USED TO MAKE CONTACT WITH THE LEAD CONNECTOR WAS DAMAGED WITH A PINHOLE TEAR IN THE SLIT. THIS ALLOWED BIOLOGIC MATERIAL TO INGRESS, RESULTING IN DEVICE CORROSION. THIS EXPOSED THE PATIENT TO CORRODED MATERIAL. THE DEVICE REMOVAL PROCEDURE ADDRESSED THIS RISK AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24405464 ↗
• MalfunctionNov 10, 2025Device Sensing Problem; Migration; Device Sensing Problem; Migration

  DURING A ROUTINE SYSTEM CHECK CLINIC VISIT, TESTING AND IMAGING IDENTIFIED A DEVICE SENSING ISSUE, WITH SUSPICION OF SEPARATION OF THE DISTAL TIP OF THE SENSING LEAD FROM THE LEAD BODY. PHYSICIAN BROUGHT THE PATIENT IN FOR SURGERY, WHERE THE SENSING LEAD BODY AND THE DETACHED DISTAL SENSOR TIP WERE RETRIEVED, AND A NEW SENSING LEAD WAS IMPLANTED TO RESTORE THERAPY. UPON CONCLUSION OF ROOT CAUSE ANALYSIS ON (B)(6) 2025, WE FOUND THAT THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY, EXPOSING THE PATIENT TO THE RISK OF INJURY FROM POSSIBLE SENSE LEAD MIGRATION. THE REVISION SURGERY ADDRESSED THE RISK, AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511642 ↗
• MalfunctionJun 18, 2025Device Sensing Problem; Device Sensing Problem

  PATIENT PRESENTED TO THE PHYSICIAN COMPLAINING OF LACK OF EFFICACY. A SYSTEM VALIDATION WAS PERFORMED, REVEALING A SUSPECTED DEVICE SENSING ISSUE. THE PATIENT WAS BROUGHT IN FOR SURGERY, AND AT THE TIME OF THE REVISION SURGERY, THE LEAD WAS REPLACED TO RESTORE THERAPY, NOT TO ADDRESS OR PREVENT SUSPECTED PATIENT INJURY. UPON CONCLUSION OF ROOT CAUSE ANALYSIS ON (B)(6) 2025, WE FOUND THAT THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY, EXPOSING THE PATIENT TO THE RISK OF INJURY FROM POSSIBLE SENSE LEAD MIGRATION. THE REVISION SURGERY ADDRESSED THE RISK AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22287849 ↗
• InjuryMay 22, 2025Migration; Migration

  PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT, WHERE IMAGING REVEALED MIGRATION OF THE SENSE LEAD INTO THE PLEURAL SPACE. TO PREVENT RISK OF COMPLICATIONS, INCLUDING PNEUMOTHORAX, THE PATIENT WAS EVALUATED BY THEIR INSPIRE PHYSICIAN AND TAKEN TO THE OPERATING ROOM. PHYSICIAN LOCATED AND RETRACTED THE SENSE LEAD FROM THE INTERCOSTAL SPACE, PLACED THE SENSE LEAD IN AN ALTERNATE LOCATION, RE-SUTURED, IRRIGATED THE INCISION SITE WITH ANTIBIOTIC SOLUTION, AND CLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22070513 ↗
• InjuryJan 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SORENESS AND A BURNING SENSATION AT THE IPG SITE WHEN USING THERAPY. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REPLACED THE IPG. AFTER IPG REPLACEMENT, THE PHYSICIAN FOUND A BREACH IN THE SENSING LEAD INSULATION. PHYSICIAN REPLACED THE SENSING LEAD AND CLOSED.

  Patient problems: Pain

  MAUDE report 21085829 ↗
• MalfunctionAug 26, 2024Device Sensing Problem; Device Sensing Problem

  AT THE TIME OF THE REVISION SURGERY, THE LEAD WAS REPLACED TO RESTORE THERAPY, NOT TO ADDRESS OR PREVENT SUSPECTED PATIENT INJURY. UPON CONCLUSION OF ROOT CAUSE ANALYSIS ON 10 AUG 2024, WE FOUND THAT THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY, EXPOSING THE PATIENT TO THE RISK OF INJURY FROM POSSIBLE SENSE LEAD MIGRATION. THE REVISION SURGERY ADDRESSED THE RISK AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20070062 ↗
• InjuryJun 27, 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 CHEST SITE WHERE THE SENSE LEAD WAS LOCATED. IMAGING WAS PERFORMED AND PHYSICIAN SUSPECTED THE SENSING LEAD MAY HAVE MIGRATED INTO THE PLEURAL SPACE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND COULD NOT CONFIRM IF THE SENSE LEAD HAD MIGRATED. PHYSICIAN DECIDED TO REMOVE THE SENSE LEAD AND PLACED A NEW SENSING LEAD IN AN ALTERNATE LOCATION.

  Patient problems: Pain

  MAUDE report 19624955 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER THE IMPLANT PROCEDURE WAS COMPLETED, THE PATIENT DEVELOPED A PNEUMOTHORAX. PHYSICIAN PLACED A CHEST TUBE AND PATIENT WAS HOSPITALIZED FOR OBSERVATION. PATIENT WAS DISCHARGED A WEEK LATER. THIS RESOLVED THE ISSUE.

  Patient problems: Pneumothorax

  MAUDE report 19537525 ↗
• InjuryApr 9, 2024Migration; Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH INTOLERABLE STIMULATION FROM THERAPY AND BURNING PAIN. IMAGING SUSPECTED THE SENSING LEAD HAD MIGRATED INTO THE LUNG. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, OPENED THE INCISION, AND CONFIRMED THE SENSING LEAD WAS IN THE PLEURAL SPACE. PHYSICIAN REPLACED THE IPG, SENSE LEAD, AND CLOSED.

  Patient problems: Pain

  MAUDE report 19073045 ↗
• MalfunctionFeb 14, 2024Device Sensing Problem; Device Sensing Problem

  AT THE TIME OF THE REVISION SURGERY, THE LEAD WAS REPLACED TO RESTORE THERAPY, NOT TO ADDRESS OR PREVENT SUSPECTED PATIENT INJURY. UPON CONCLUSION OF ROOT CAUSE ANALYSIS ON 30 JAN 2024, WE FOUND THAT THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY, EXPOSING THE PATIENT TO THE RISK OF INJURY FROM POSSIBLE SENSE LEAD MIGRATION. THE REVISION SURGERY ADDRESSED THE RISK AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707536 ↗
• InjuryDec 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH STABBING PAIN UNDER THE IPG. PHYSICIAN ORDERED IMAGING AND OBSERVED A PLEURAL EFFUSION. IMAGING SHOWED A WELL-PLACED SENSING LEAD WITH NO PENETRATION INTO THE THORACIC CAVITY. FLUID WAS DRAINED. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE IPG AND SENSING LEAD WITH PLANS TO RE-IMPLANT THE PATIENT LATER.

  Patient problems: Pain

  MAUDE report 18288569 ↗
• MalfunctionDec 4, 2023Device Sensing Problem; Device Sensing Problem

  AT THE TIME OF THE REVISION SURGERY, (B)(6) 2023, THE LEAD WAS REPLACED TO RESTORE THERAPY. INSPIRE WAITED FOR THE PRODUCT TO RETURN FROM PATHOLOGY, HOWEVER THE EXPLANTED PRODUCT WAS NEVER RETURNED TO INSPIRE. THE ROOT CAUSE ANALYSIS WAS COMPLETED ON (B)(6) 2023 WITHOUT A RETURN. BASED ON INFORMATION FROM THE PROCEDURE, WE CONCLUDED THAT THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY, EXPOSING THE PATIENT TO THE RISK OF INJURY FROM POSSIBLE SENSE LEAD MIGRATION. THE REVISION SURGERY ADDRESSED THE RISK, AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18258787 ↗
• InjuryNov 27, 2023Device Sensing Problem; Device Sensing Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH CHEST PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND REPLACED THE SENSING LEAD. THIS RESOLVED THE ISSUE.

  Patient problems: Pain

  MAUDE report 18212459 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN IN THE CHEST AREA. PHYSICIAN ORDERED IMAGING AND THOUGHT THE SENSING LEAD WAS IMPLANTED DEEP. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REMOVED THE OLD SENSING LEAD, DISSECTED THE AREA, AND PLACED THE SENSING LEAD MORE LATERAL. PATIENT PRESENTED BACK TO THE PHYSICIAN POST-PROCEDURE WITH A FEVER AND AN INFECTION. PHYSICIAN PRESCRIBED ANTIBIOTICS AND DETERMINED THE PATIENT HAD A VIRAL INFECTION.

  Patient problems: Fever; Pain; Unspecified Infection

  MAUDE report 18188230 ↗
• MalfunctionOct 23, 2023Device Sensing Problem; Device Sensing Problem

  PATIENT PRESENTED BACK TO THE PHYSICIAN WITH FRACTURED SENSING LEAD TIP STILL IN THE BODY. CARDIOTHORACIC SURGEON BROUGHT THE PATIENT INTO THE OPERATING ROOM AND RETRIEVED THE SEVERED SENSING LEAD TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17992806 ↗
• MalfunctionOct 3, 2023Device Sensing Problem; Device Sensing Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SHOCKING SENSATION IN THE RIGHT ABDOMEN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND AT THE TIME OF THE REVISION SURGERY, THE LEAD WAS REPLACED TO RESTORE THERAPY, NOT TO ADDRESS OR PREVENT SUSPECTED PATIENT INJURY. UPON CONCLUSION OF ROOT CAUSE ANALYSIS ON 14 SEP 2023, WE FOUND THAT THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY, EXPOSING THE PATIENT TO THE RISK OF INJURY FROM POSSIBLE SENSE LEAD MIGRATION. THE REVISION SURGERY ADDRESSED THE RISK AND THE ISSUE IS NOW RESOLVED.

  Patient problems: Shock from Patient Lead(s)

  MAUDE report 17861987 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED BACK TO THE PHYSICIAN WITH A REOCCURRING INFECTION AT THE CHEST INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE STIMULATION AND SENSING LEAD.

  Patient problems: Unspecified Infection

  MAUDE report 17822083 ↗
• MalfunctionSep 26, 2023Device Sensing Problem; Device Sensing Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH COMPLAINT OF LACK OF EFFICACY. CT SCAN WAS PERFORMED AND THE DISTAL TIP OF THE SENSOR WAS BELIEVED TO HAVE MIGRATED. THE PATIENT WAS BROUGHT IN FOR AN EXPLANT SURGERY, WITH A CARDIOTHORACIC SURGEON PRESENT TO REMOVE THE DISTAL SENSOR TIP. THE EXPLANT WAS COMPLETED ON (B)(6)2023. DURING THE PROCEDURE A CHEST TUBE WAS PLACED TEMPORARILY AND PATIENT WAS ADMITTED OVERNIGHT. THE CHEST TUBE WAS REMOVED PRIOR TO RELEASE THE NEXT DAY. THE SURGERY ADDRESSED THE RISK AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17816873 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH LUNG PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE IPG, SENSE LEAD, AND THE STIMULATION LEAD BODY.

  Patient problems: Pain

  MAUDE report 17776888 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE SITE OF THE INSPIRE DEVICE. PHYSICIAN PRESCRIBED ANTIBIOTICS AND PAIN MEDICATION.

  Patient problems: Pain

  MAUDE report 17455443 ↗
• MalfunctionAug 2, 2023Device Sensing Problem; Device Sensing Problem

  AT THE TIME OF THE REVISION SURGERY, (B)(6) 2023, THE LEAD WAS REPLACED TO RESTORE THERAPY. INSPIRE WAITED FOR THE PRODUCT TO RETURN FROM PATHOLOGY, HOWEVER THE EXPLANTED PRODUCT WAS NEVER RETURNED TO INSPIRE. THE ROOT CAUSE ANALYSIS WAS COMPLETED ON (B)(6) 2023 WITHOUT A RETURN. BASED ON INFORMATION FROM THE PROCEDURE, WE CONCLUDED THAT THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY, EXPOSING THE PATIENT TO THE RISK OF INJURY FROM POSSIBLE SENSE LEAD MIGRATION. THE REVISION SURGERY ADDRESSED THE RISK, AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446264 ↗
• InjuryJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH BACK PAIN NEAR THE SPINE AND SIDE PAIN. PATIENT MENTIONED RECEIVING MASSAGE AND GOLFING AS EXTRA-CURRICULAR ACTIVITIES. PHYSICIAN ADMINISTERED STEROID INJECTIONS. PATIENT PRESENTED BACK TO THE PHYSICIAN WITH CONTINUED SIDE PAIN. PHYSICIAN SUSPECTS THE DEVICE COULD BE IMPINGING ON A NERVE.

  Patient problems: Pain

  MAUDE report 17232826 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED A ROUTINE EXAMINATION AND DURING THE EXAM EXPERIENCED PAIN IN THE CHEST AREA. PATIENT WAS BROUGHT TO THE ER. IMAGING WAS COMPLETED AND IT APPEARED THAT THE SENSING LEAD TIP WAS IN THE PLEURAL SPACE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR TO REMOVE THE IPG AND SENSOR LEAD. UPON REMOVAL OF THE LEAD TIP THE LUNG PRESSURE DROPPED. ALBUTEROL WAS PROVIDED AND THE PRESSURE NORMALIZED. PHYSICIAN SUSPECTS THE SENSING LEAD TIP WAS PUSHING ON THE PLEURA.

  Patient problems: Pain

  MAUDE report 16886774 ↗

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