Inspire 900-009-002Recalls & reported problems

Summary

The FDA's MAUDE database contains 138 adverse event reports that list this exact device (DI 10855728005632), received between Oct 8, 2019 and Apr 30, 2026 — classified as 84 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (74 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 138 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Device Sensing Problem; Migration

  DURING A SYSTEM CHECK CLINIC VISIT DUE TO THERAPY DISCOMFORT, THE PHYSICIAN OBSERVED A DEVICE SENSING ISSUE. PHYSICIAN BROUGHT THE PATIENT IN FOR SURGERY AND FOUND THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY AND HAD MIGRATED AFTER SEPARATION. PHYSICIAN DETERMINED THAT ATTEMPTING RETRIEVAL OF THE SENSOR TIP WOULD EXPOSE THE PATIENT TO GREATER RISK AND DECIDED TO LEAVE THE SENSOR BEHIND IN THE PATIENT. THE PHYSICIAN RETRIEVED THE REMAINING SENSE LEAD, EXPLANTED THE IPG, AND IMPLANTED A NEWER IPG MODEL THAT DOES NOT REQUIRE A SENSING LEAD. THE INCISION WAS SUTURED AND CLOSED WITH NO FURTHER ISSUES. THE REVISION SURGERY RESTORED THERAPY, AND THE ISSUE IS NOW RESOLVED.

  Patient problems: Discomfort

  MAUDE report 25053619 ↗
• InjuryApr 29, 2026Device Sensing Problem; Migration

  DURING A ROUTINE SYSTEM CHECK CLINIC VISIT, THE PHYSICIAN OBSERVED A DEVICE SENSING ISSUE. PHYSICIAN BROUGHT THE PATIENT IN FOR SURGERY AND FOUND THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY AND HAD MIGRATED AFTER SEPARATION. PHYSICIAN DETERMINED THAT ATTEMPTING RETRIEVAL OF THE SENSOR TIP WOULD EXPOSE THE PATIENT TO GREATER RISK AND DECIDED TO LEAVE THE SENSOR BEHIND IN THE PATIENT. THE PHYSICIAN RETRIEVED THE REMAINING SENSE LEAD, EXPLANTED THE IPG, AND IMPLANTED A NEWER IPG MODEL THAT DOES NOT REQUIRE A SENSING LEAD. THE INCISION WAS SUTURED AND CLOSED WITH NO FURTHER ISSUES. THE REVISION SURGERY RESTORED THERAPY, AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25037682 ↗
• InjuryMar 17, 2026Migration

  PATIENT PRESENTED BACK TO THE PHYSICIAN AFTER CONFIRMATION THAT THE SENSING LEAD HAD MIGRATED INTO THE PLEURAL SPACE, CAUSING PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND EXPLANTED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 24619182 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PERSISTENT PAIN AT THE RIBCAGE. PHYSICIAN BROUGHT THE PATIENT TO THE OR, EXPLANTED THE IPG AND SENSING LEAD, IMPLANTED A NEWER IPG MODEL THAT DOES NOT REQUIRE A SENSING LEAD, SUTURED THE TISSUE, AND CLOSED THE INCISION. POST-OPERATIVE ANTIBIOTICS WERE PRESCRIBED.

  Patient problems: Pain

  MAUDE report 24558665 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  AFTER WEIGHT LOSS, THE PATIENT PRESENTED TO THE PHYSICIAN WITH RIB PAIN NEAR THE SENSING LEAD SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, REMOVED THE IPG AND SENSE LEAD, AND IMPLANTED A NEWER IPG MODEL THAT DOES NOT REQUIRE A SENSING LEAD. THE NEW IPG WAS PLACED IN A TYRX POUCH, ANTIBIOTIC POWDER WAS APPLIED TO THE AREA, AND THE INCISION WAS CLOSED.

  Patient problems: Pain

  MAUDE report 24394853 ↗
• MalfunctionJan 20, 2026Detachment of Device or Device Component; Device Sensing Problem

  DURING A ROUTINE SYSTEM CHECK CLINIC VISIT, THE PHYSICIAN OBSERVED A DEVICE SENSING ISSUE. PHYSICIAN BROUGHT THE PATIENT IN FOR SURGERY AND FOUND THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY. HOWEVER, THE SURGEON SUCCESSFULLY RETRIEVED THE SENSOR TIP WITHOUT COMPLICATIONS. UPON CONCLUSION OF ROOT CAUSE ANALYSIS COMPLETED ON 8 JAN 2026, IT WAS DETERMINED THAT THE DISTAL SENSOR TIP HAD DETACHED 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 24124878 ↗
• MalfunctionJan 19, 2026Device Sensing Problem

  DURING A ROUTINE SYSTEM CHECK CLINIC VISIT, THE PHYSICIAN OBSERVED A DEVICE SENSING ISSUE. PHYSICIAN BROUGHT THE PATIENT IN FOR SURGERY AND FOUND THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY AND HAD MIGRATED AFTER SEPARATION. THE PHYSICIAN DETERMINED THAT ATTEMPTING RETRIEVAL OF THE SENSOR TIP WOULD EXPOSE THE PATIENT TO GREATER RISK AND DECIDED TO LEAVE THE SENSOR BEHIND IN THE PATIENT. PHYSICIAN RETRIEVED THE REMAINING SENSE LEAD AND PLACED A NEW SENSING LEAD WITH NO FURTHER ISSUES. THE REVISION SURGERY RESTORED THERAPY, AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111599 ↗
• InjuryDec 1, 2025Device Sensing Problem; Device Sensing Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE THIRD INCISION, WHERE THE SENSING LEAD IS LOCATED. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REMOVED THE SENSING LEAD, IMPLANTED A NEWER IPG MODEL, WHICH DOES NOT REQUIRE A SENSING LEAD, SUTURED, AND CLOSED.

  Patient problems: Pain

  MAUDE report 23682754 ↗
• InjuryOct 31, 2025Migration; Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH RIGHT-SIDED CHEST PAIN. IMAGING WAS PERFORMED, REVEALING THAT THE SENSING LEAD HAD MIGRATED INTO THE LUNG. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REMOVED THE IPG, SENSING LEAD, AND A PORTION OF THE STIMULATION LEAD, AND CLOSED. THIS RESOLVED THE ISSUE.

  Patient problems: Pain

  MAUDE report 23438544 ↗
• InjuryOct 30, 2025Device Sensing Problem; Device Sensing Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE RIBS NEAR THE INCISION WHERE THE SENSE LEAD WAS PLACED. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, AND UPON ENTERING THE INTERCOSTAL SPACE, IT WAS OBSERVED THAT THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY. DUE TO THE RISK FROM POSSIBLE SENSE LEAD MIGRATION, THE PHYSICIAN RETRIEVED AND REMOVED THE ENTIRE SENSING LEAD AND IMPLANTED A NEWER IPG MODEL, WHICH DOES NOT REQUIRE A SENSING LEAD, RE-SUTURED, AND CLOSED.

  Patient problems: Pain

  MAUDE report 23428313 ↗
• InjuryOct 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN IN THE RIB NEAR THE SITE OF THE SENSING LEAD PLACEMENT. 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, RE-SUTURED, AND CLOSED.

  Patient problems: Pain

  MAUDE report 23408874 ↗
• InjuryOct 15, 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 SITE OF THE SENSING LEAD PLACEMENT. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND, UPON SURGICAL EXPLORATION, THE SENSING LEAD WIRE WAS FOUND COILED AT THE INCISION SITE. PHYSICIAN REMOVED THE ENTIRE INSPIRE SYSTEM, IMPLANTED A NEW SYSTEM, AND CLOSED.

  Patient problems: Pain

  MAUDE report 23285129 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SORENESS AT THE RIB FOLLOWING A FALL AND REPORTED BEING ABLE TO FEEL THE SENSING LEAD ANCHOR. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, AND UPON SURGICAL EXPLORATION, IT WAS OBSERVED THAT THE SENSING LEAD ANCHORING STITCH HAD PULLED AWAY AND DETACHED FROM THE MUSCLE. PHYSICIAN RE-SUTURED THE SENSING LEAD ANCHOR SECURELY AND CLOSED THE INCISION. THIS RESOLVED THE ISSUE.

  Patient problems: Pain

  MAUDE report 22903490 ↗
• InjuryMay 20, 2025Positioning Problem; Positioning Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH RIB PAIN LOCALIZED AT THE SITE OF THE PLACED SENSE LEAD. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REMOVED THE ORIGINAL SENSE LEAD, PLACED A NEW SENSE LEAD IN AN ALTERNATE LOCATION, RE-SUTURED, AND CLOSED THE INCISION SITE. THIS RESOLVED THE ISSUE.

  Patient problems: Pain

  MAUDE report 22053002 ↗
• MalfunctionMay 6, 2025Device Sensing Problem; Device Sensing Problem

  DURING A ROUTINE EXAMINATION, THE PHYSICIAN IDENTIFIED A DEVICE SENSING ISSUE. IMAGING WAS PERFORMED, AND THE DISTAL TIP OF THE SENSING LEAD WAS SUSPECTED TO HAVE SEPARATED FROM THE LEAD BODY. THE PATIENT WAS BROUGHT IN FOR REVISION SURGERY, WHICH CONFIRMED THAT THE DISTAL SENSOR TIP HAD DETACHED AND MIGRATED INTO THE PLEURAL. DUE TO THE POTENTIAL RISK INVOLVED IN RETRIEVAL, THE PHYSICIAN ELECTED TO ABANDON THE MIGRATED SENSOR TIP. A NEW SENSING LEAD WAS SUCCESSFULLY IMPLANTED, RESTORING THERAPY. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS, AND THE ISSUE HAS BEEN RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21973106 ↗
• InjuryFeb 26, 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 SENSE LEAD INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REPLACED THE SENSING LEAD.

  Patient problems: Pain

  MAUDE report 21470452 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN ON THE RIGHT SIDE AFTER A FALL. IMAGING WAS DONE AND IT SHOWED THAT THE SENSE LEAD HAS MIGRATED FROM THE ORIGINAL PLACEMENT. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND CONFIRMED THE SENSE LEAD HAD ADVANCED. PHYSICIAN REPLACED THE SENSE LEAD, RE-SUTURED, AND CLOSED.

  Patient problems: Pain

  MAUDE report 21459974 ↗
• MalfunctionJan 8, 2025Device Sensing Problem; Device Sensing Problem

  DURING A ROUTINE FOLLOW-UP EXAMINATION, THE PHYSICIAN OBSERVED A DEVICE SENSING ISSUE. IMAGING WAS PERFORMED AND THE DISTAL TIP OF THE SENSING LEAD WAS SUSPECTED OF SEPARATING FROM THE LEAD BODY. PHYSICIAN BROUGHT THE PATIENT IN FOR SURGERY AND FOUND THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY AND MIGRATED. THE PHYSICIAN DETERMINED THAT RETRIEVING THE SENSOR WOULD EXPOSE THE PATIENT TO GREATER RISK AND OPTED TO ABANDON THE SENSOR. PHYSICIAN REPLACED THE SENSING LEAD WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21108394 ↗
• MalfunctionDec 13, 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. HOWEVER, UPON ENTERING THE SPACE, THE SURGEON FOUND THAT THE DISTAL SENSOR TIP WAS SEVERED AND HAD MIGRATED TO THE PLEURA. SURGEON WAS ABLE TO RETRIEVE THE SENSOR TIP. UPON CONCLUSION OF ROOT CAUSE ANALYSIS ON (B)(6) 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 20929024 ↗
• MalfunctionDec 3, 2024Device Sensing Problem; Device Sensing Problem

  DURING A ROUTINE SYSTEM CHECK CLINIC VISIT THE PHYSICIAN OBSERVED A DEVICE SENSING ISSUE. PHYSICIAN BROUGHT THE PATIENT IN FOR SURGERY AND FOUND THAT THE DISTAL SENSOR TIP WAS CALCIFIED AND HAD BEEN SEVERED. THE PHYSICIAN DETERMINED THAT RETRIEVING THE SENSOR WOULD EXPOSE THE PATIENT TO GREATER RISK AND DECIDED TO LEAVE THE SENSOR BEHIND IN THE PATIENT. THE PHYSICIAN REPLACED THE SENSING LEAD WITH NO FURTHER ISSUES. THE REVISION SURGERY RESTORED THERAPY AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835999 ↗
• MalfunctionNov 14, 2024Device Sensing Problem; Device Sensing Problem

  THE PATIENT UNDERWENT A SURGERY ON (B)(6) 2025, TO RETRIEVE A MIGRATED SENSE LEAD BODY TIP. THE SURGEON MADE 4 INCISIONS AND COLLAPSED THE PATIENT'S LUNG TO GAIN ACCESS TO THE SENSOR TIP AND RETRIEVE IT. THE SURGEON PLACED A CHEST TUBE AFTER THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20692190 ↗
• MalfunctionNov 11, 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(B)(6) 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 20652372 ↗
• MalfunctionOct 28, 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 (B)(6) 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 20551914 ↗
• MalfunctionSep 24, 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 (B)(6) 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 20291442 ↗
• InjurySep 11, 2024Device Sensing Problem; Migration; Device Sensing Problem; Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH A LACK OF EFFICACY FROM THE INSPIRE SYSTEM. A SYSTEM CHECK WAS PERFORMED AT THE CLINIC VISIT WHERE THE PHYSICIAN OBSERVED A DEVICE SENSING ISSUE. CT SCAN WAS PERFORMED AND THE DISTAL TIP OF THE SENSING LEAD WAS FOUND TO HAVE MIGRATED INTO THE PLEURAL SPACE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND CONFIRMED THAT THE DISTAL SENSOR TIP HAD MIGRATED. PHYSICIAN REPLACED THE SENSING LEAD WITH NO FURTHER ISSUES. THE REVISION SURGERY RESTORED THERAPY AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20195970 ↗

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