Inspire 900-002-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10855728005403), received between Aug 17, 2018 and Jan 29, 2025 — classified as 4 injuries, 5 malfunctions.

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 29, 2025Device 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) 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 21267648 ↗
• MalfunctionMay 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT THE TIME OF THE REVISION SURGERY, (B)(6) 2022, 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 28 APR 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 16987183 ↗
• InjuryApr 1, 2019Migration; Migration

  ADDITIONAL INFORMATION: IPG POCKET INCISION WAS OPENED ON (B)(6) 2019 IN SURGERY TO BE CLEANED, CULTURED, AND TO ADMINISTER ANTIBIOTICS TYRX POUCH WAS PLACED AROUND THE IPG AND VANCOMYCIN POWDER WAS ADMINISTERED INTO THE INCISION SITE. THE FULL SYSTEM WAS EXPLANTED ON (B)(6) 2019 TO RESOLVE THE INFECTION.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 8471223 ↗
• InjuryMar 22, 2019Migration; Migration

  THE PATIENT'S DEVICE WAS ACTIVATED ON (B)(6) 2019 AT THE PHYSICIAN'S OFFICE. AT THIS VISIT, THE PATIENT REPORTED HE WAS FEELING BETTER AFTER HAVING HIS LUNG DRAINED. THE PATIENT WAS SUCCESSFULLY ACTIVATED WITHOUT ISSUE.

  Patient problems: Pleural Effusion

  MAUDE report 8444271 ↗
• InjuryFeb 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PNEUMOTHORAX FOUND ON CHEST X-RAY FOLLOWING IMPLANT PROCEDURE. DOCTOR BELIEVES IT WAS CAUSED DURING TUNNELING. THE PATIENT HAD A CHEST TUBE PLACED AND WAS KEPT IN THE HOSPITAL OVERNIGHT.

  Patient problems: Pneumothorax

  MAUDE report 8346070 ↗
• MalfunctionSep 18, 2018Device Sensing Problem; Material Split, Cut or Torn; Device Sensing Problem; Material Split, Cut or Torn

  DURING THE IPG RE POSITIONING FOR COSMETIC PURPOSES, A BREACH IN THE SENSING LEAD INSULATION WAS NOTICED. IT WAS NOT ADDRESSED DURING THIS INITIAL REVISION PROCEDURE. THERAPY WAS DISCONTINUED AND ANOTHER PROCEDURE WAS DONE TO REPLACE THE SENSING LEAD AND RESTORE THERAPY. THIS RESOLVED THE ISSUE.

  Patient problems: Not Applicable

  MAUDE report 7885848 ↗
• InjuryAug 28, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT EXPERIENCED DISCOMFORT AND RADIATING PAIN IN THE INTERCOSTAL AREA NEAR THE SENSING LEAD AS WELL AS HEADACHES AND RESTLESS SLEEP. SHE ALSO STATED THAT WHEN SHE AWAKENS THAT SHE GETS 3-4 QUICK PULSES FROM THE THERAPY. PATIENT WILL BE RETURNING TO THE CLINIC FOR A FOLLOW UP REGARDING THESE ISSUES.

  Patient problems: Pain

  MAUDE report 7825023 ↗
• MalfunctionAug 28, 2018Impedance Problem; Impedance Problem

  FOLLOW UP REPORT ON 3007666314-2018-00027: INITIAL REPORT HAD A "DATE RECEIVED BY MANUFACTURER" OF 21-AUG-2018. HOWEVER SINCE FILING THE INITIAL REPORT MANUFACTURER HAS LEARNED THAT A COMPANY REPRESENTATIVE WAS AWARE PRIOR TO THAT DATE. THE ACTUAL "MANUFACTURERS AWARENESS DATE" SHOULD BE 11-SEP-2017. THE PURPOSE OF THIS FOLLOW UP REPORT IS TO MAKE THAT CORRECTION.

  Patient problems: No Code Available

  MAUDE report 7824206 ↗
• MalfunctionAug 17, 2018Impedance Problem; Impedance Problem

  PATIENT WAS ACTIVATED AND TONGUE MOTION WAS POSITIVE. SENSE AND FUNCTIONAL THRESHOLDS WERE CAPTURED. HOWEVER ABNORMAL IMPEDANCE VALUES WERE NOTED AND THERAPY ACTIVATION WAS POSTPONED. THERE WAS NO PATIENT INJURY HOWEVER, UNUSUAL IMPEDANCE READINGS PROMPTED THE PHYSICIAN TO DO A REVISION SURGERY TO REPLACE THE SENSE LEAD ON (B)(6) 2018.

  Patient problems: No Code Available

  MAUDE report 7793338 ↗

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