Inspire 900-002-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00855728005192), received between Oct 4, 2018 and Nov 17, 2025 — classified as 7 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 17, 2025Device Sensing Problem; Migration; Device Sensing Problem; Migration

  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 REMOVED THE SENSE LEAD BODY BUT DETERMINED THAT RETRIEVING THE SENSOR WOULD EXPOSE THE PATIENT TO GREATER RISK AND OPTED TO ABANDON THE SENSOR. A NEWER IPG MODEL, WHICH DOES NOT REQUIRE A SENSING LEAD, WAS IMPLANTED WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23575751 ↗
• InjurySep 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SEVERE PAIN AT THE RIBS WHERE THE SENSING LEAD IS LOCATED. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, EXAMINED THE AREA, AND FOUND THAT THE SENSE LEAD WENT UNDERNEATH THE RIB SPACE IN PROXIMITY OF THE STERNUM. PHYSICIAN REMOVED THE IPG, STIMULATION LEAD, AND A PORTION OF THE SENSING LEAD. PHYSICIAN DECIDED THAT REMOVING THE REMAINDER OF THE SENSING LEAD COULD INJURE THE PATIENT AND MADE THE DECISION TO LEAVE THE REMAINDER OF THE COMPONENT. PATIENT PRESENTED BACK TO THE PHYSICIAN WITH CONTINUED DISCOMFORT AT THE RIB AREA. PHYSICIAN WILL BE COLLABORATING WITH A THORACIC SURGEON TO SCHEDULE A SECOND SURGERY TO REMOVE THE SENSOR TIP AT A LATER DATE.

  Patient problems: Pain

  MAUDE report 20301538 ↗
• InjuryJul 16, 2024Adverse 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 NEAR THE SENSE LEAD INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REPLACED THE SENSING LEAD.

  Patient problems: Pain

  MAUDE report 19754698 ↗
• MalfunctionJul 15, 2024Device Sensing Problem; Device Sensing Problem

  DURING A ROUTINE SYSTEM CHECK CLINIC VISIT 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 IN FOR SURGERY AND CONFIRMED THAT THE DISTAL SENSOR TIP WAS SEVERED AND HAD MIGRATED TO THE PLEURA. A THORACIC SURGEON WAS BROUGHT IN AND WAS ABLE TO RETRIEVE THE SENSOR TIP. THE PHYSICIAN REPLACED THE SENSING LEAD AND IPG 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 19746677 ↗
• MalfunctionJun 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 (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 19537748 ↗
• InjuryApr 3, 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 SENSING LEAD SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REPLACED THE SENSING LEAD.

  Patient problems: Pain

  MAUDE report 19032807 ↗
• InjuryJun 16, 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 SENSE LEAD INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND REPLACED THE SENSING LEAD.

  Patient problems: Pain

  MAUDE report 17148363 ↗
• InjuryJun 15, 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 SENSING LEAD SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REPLACED, AND RELOCATED THE SENSING LEAD.

  Patient problems: Pain

  MAUDE report 17134588 ↗
• MalfunctionApr 25, 2023Device Sensing Problem; Device Sensing Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH LACK OF EFFICACY AND HEALTH ISSUES REQUIRING MRI AND REQUESTED REMOVAL OF THE DEVICE. AT THE TIME OF THE SURGERY, (B)(6) 2023, THE SENSOR TIP WAS FOUND TO HAVE SEPARATED FROM THE LEAD BODY AND TO HAVE MIGRATED AFTER SEPARATION. 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 REVISION SURGERY RESTORED THERAPY AND THE ISSUE IS NOW RESOLVED.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16807190 ↗
• InjuryJan 6, 2021Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT PRESENTED TO THE PHYSICIAN WITH A LUMP AT THE SENSE LEAD INCISION SITE. PATIENT RECEIVED CT SCAN WHICH SHOWED THE SENSE LEAD ERODING INTO THE PLEURAL SPACE. THE PHYSICIAN SURGICALLY REMOVED THE SENSOR, WHICH WAS IN A THICK FIBROTIC CAPSULE. THIS RESOLVED THE ISSUE AND ANOTHER SENSOR WAS IMPLANTED.

  Patient problems: Erosion

  MAUDE report 11127603 ↗
• InjuryFeb 15, 2019Malposition of Device; Malposition of Device

  PATIENT UNDERWENT A SENSING LEAD REVISION. THE LEAD WAS NOT REPLACED OR EXPLANTED. THE LEAD'S STRAIN-RELIEF WAS INCREASED TO ADDRESS DEVICE TRACTION. THE LEAD WAS TESTED AFTER BEING REPOSITIONED AND PERFORMED ADEQUATELY.

  Patient problems: Neck Pain

  MAUDE report 8345438 ↗
• MalfunctionOct 4, 2018Device Sensing Problem; Device Sensing Problem

  PATIENT FELT THAT HIS IPG MAY HAVE SHIFTED POSITION AND THE SENSE LEAD WAS PROVIDING ABNORMAL WAVEFORMS AND IMPEDANCE READINGS. REVISION SURGERY WAS CONDUCTED TO REPLACE THE SENSE LEAD AND ADDRESS DEVICE MIGRATION.

  Patient problems: No Code Available

  MAUDE report 7936255 ↗

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