Inspire 900-007-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10855728005762), received between Jun 22, 2021 and Jan 14, 2026 — classified as 8 injuries.

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 18, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH A LUMP AT THE NECK INCISION SITE FROM THE LEAD WIRES AND PAIN AT THE IPG SITE FOLLOWING WEIGHT LOSS. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 24075892 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH TENDERNESS AND SWELLING AT THE CHEST INCISION SITE. PHYSICIAN PRESCRIBED ANTIBIOTICS.

  Patient problems: Swelling/ Edema

  MAUDE report 23978911 ↗
• InjuryJul 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PERSISTENT DYSARTHRIA, NECK PAIN, AND CHEST PAIN. DUE TO THE SYMPTOMS AND THE PATIENT'S WEIGHT LOSS WITH A REDUCTION IN APNEA-HYPOPNEA INDEX (AHI), THE PATIENT ELECTED SYSTEM REMOVAL. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Pain; Speech Disorder

  MAUDE report 22559623 ↗
• InjuryOct 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH AN INFECTION AT THE IPG SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REMOVED THE IPG, CAPPED THE REMAINING LEADS, AND CLOSED.

  Patient problems: Unspecified Infection

  MAUDE report 20577165 ↗
• InjuryMay 10, 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 IPG SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND EXPLANTED THE IPG, SENSING LEAD, AND A MAJORITY OF THE STIMULATION LEAD.

  Patient problems: Pain

  MAUDE report 19288968 ↗
• InjuryFeb 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE ER PHYSICIAN WITH CONCERNS OF INFECTION. ER PHYSICIAN DETERMINED THAT THE PATIENT DID NOT HAVE AN INFECTION. PATIENT PRESENTED TO THEIR INSPIRE-TRAINED PHYSICIAN WITH CONCERNS OF INFECTION. PHYSICIAN EVALUATED THE PATIENT AND DETERMINED THE IPG HAD MIGRATED AND THAT THERE WAS SIGNIFICANT TETHERING FROM THE STIMULATION LEAD. PHYSICIAN BROUGHT THE PATIENT TO THE OR AND CONFIRMED INFECTION AT THE IPG SITE. PHYSICIAN REMOVED THE ENTIRE INSPIRE SYSTEM, FLUSHED THE AREA WITH ANTIBIOTICS, AND PRESCRIBED ORAL ANTIBIOTICS AFTER THE PROCEDURE WAS COMPLETED.

  Patient problems: Unspecified Infection

  MAUDE report 18785010 ↗
• InjuryAug 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH WOUND DEHISCENCE AND DRAINAGE. PHYSICIAN PRESCRIBED ANTIBIOTICS.

  Patient problems: Wound Dehiscence

  MAUDE report 17498377 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH EROSION AT THE SENSE LEAD INCISION SITE THROUGH WHICH THE SUTURE ANCHOR WAS VISIBLE. PHYSICIAN SURGICALLY REPLACED THE SENSE LEAD ON (B)(6) 2021, RESOLVING THE ISSUE.

  Patient problems: Erosion; Unspecified Infection; Wound Dehiscence

  MAUDE report 12042434 ↗

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