Inspire 900-002-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10855728005496), received between Oct 4, 2018 and Nov 19, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Sensing Problem” (2 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2025Device Sensing Problem; Device Sensing Problem

  DURING A ROUTINE FOLLOW-UP EXAMINATION, PHYSICIAN OBSERVED A DEVICE SENSING ISSUE. THE PATIENT REPORTED SEVERE, PAINFUL SHOCKING SENSATIONS DEEPER IN THE CHEST, PREVENTING THEM FROM LYING DOWN. 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 CONFIRMED THE DISTAL SENSOR TIP HAD SEPARATED FROM THE LEAD BODY AND MIGRATED. THE PHYSICIAN CONSULTED WITH A CARDIOTHORACIC SURGEON AND DEEMED RETRIEVAL WAS A HIGHER RISK TO THE PATIENT, SO THE SENSOR WAS ABANDONED. THE PHYSICIAN REMOVED THE SENSE LEAD BODY AND IMPLANTED A NEWER IPG MODEL, WHICH DOES NOT REQUIRE A SENSING LEAD, WITH NO FURTHER ISSUES.

  Patient problems: Pain

  MAUDE report 23596407 ↗
• InjuryMar 5, 2019Malposition of Device; Malposition of Device

  DURING IMPLANT, THE SENSING LEAD PENETRATED THE SPACE BETWEEN THE INTERNAL INTERCOSTALS AND LUNG. THE ISSUE WAS RECOGNIZED, THE AREA WAS OVERSEWN WITH TWO LAYERS OF SUTURE. THE AREA WAS FLOODED WITH SALINE, ANESTHESIA PERFORMED VALSALVA WITHOUT ANY BUBBLES BEING SEEN. THE LEAD WAS THEN MOVED TO A DIFFERENT RIB SPACE SUCCESSFULLY. POST-OP CHEST X-RAY DID NOT SHOW PNEUMOTHORAX. THE PATIENT WAS CLINICALLY ASYMPTOMATIC AND DISCHARGED PER USUAL.

  Patient problems: Infiltration into Tissue

  MAUDE report 8391027 ↗
• InjuryOct 8, 2018Use of Device Problem; Use of Device Problem

  DURING TUNNELLING, PRIOR TO PLACEMENT OF THE SENSOR LEAD, PHYSICIAN WAS USING A MALLEABLE RIBBON RETRACTOR WHICH IS NOT AN INSPIRE PRODUCT. THE RETRACTOR WAS PLACED INTO THE INTERCOSTAL SPACE BUT PLANED SLIGHTLY BELOW THE INTERNAL INTERCOSTAL FIBERS. A SLIGHT NOISE WAS NOTED AND SOME SMALL BUBBLES WERE OBSERVED. CORRECTIVE MEASURES WERE TAKEN TO MANAGE WHAT APPEARED TO BE A SMALL PNEUMOTHORAX. NO LUNG COLLAPSE OR VOLUME CHANGE WAS NOTED AND ONCE IT WAS DETERMINED THE SITUATION WAS STABLE THE SENSOR WAS PLACED AND THE CASE COMPLETED AS NORMAL. THE PATIENT WAS OBSERVED AND NO FURTHER COMPLICATIONS WERE NOTED.

  Patient problems: Pneumothorax

  MAUDE report 7945364 ↗
• InjuryOct 8, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING A SURGICAL PROCEDURE UNRELATED TO INSPIRE THERAPY THE SURGEON OBSERVED THAT THE SENSING LEAD, IMPLANTED 2.5 YEARS EARLIER, WAS PLACED IN THE PLEURAL SPACE. THERE IS NO PATIENT INJURY AND THE THERAPY IS WORKING WELL, BUT IT APPEARS THAT THE PATIENT EXPERIENCED A SELF HEALING PNEUMOTHORAX DURING THE IMPLANT PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 7945197 ↗
• MalfunctionOct 4, 2018Device Sensing Problem; Device Sensing Problem

  INITIAL REPORT WAS THAT PATIENT REQUIRED DEVICE SETTING ADJSUTMENTS BUT SUBSEQUENTLY IT WAS MADE KNOWN TO INSPIRE THAT ISSUES WITH SENSING AND WAVEFORMS LED TO TWO REVISION SURGERIERS, ONE TO REPLACE THE SENSING LEAD (B)(6) 2018), AND THEN LATER (B)(6) 2018) THE IPG WAS REPLACED. THIS RESOLVED THE ISSUES AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7936254 ↗

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