Inspire 900-007-014Recalls & reported problems

Summary

The FDA's MAUDE database contains 1,012 adverse event reports that list this exact device (DI 10855728005915), received between Oct 25, 2022 and Sep 30, 2026 — classified as 3 deaths, 1,006 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Migration” (100 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 1,012 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Migration

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50949709 ↗
• InjurySep 30, 2026Migration

  Patient presented to the physician with movement of the IPG within the pocket, causing pain. Imaging was obtained, showing that the IPG appeared to have shifted downward. Physician brought the patient into the OR, re-sutured the IPG securely, and closed.

  Patient problems: Pain

  MAUDE report 50949538 ↗
• InjuryAug 27, 2026Migration

  Patient presented to the physician with flipping and movement of the IPG within the pocket, resulting in pain. Physician brought the patient into the OR, re-sutured the IPG, and closed.

  Patient problems: Pain

  MAUDE report 50484048 ↗
• InjuryAug 26, 2026Migration

  Patient presented to the physician with flipping of the IPG within the pocket, posing a potential risk of injury. Physician brought the patient into the OR, and upon surgical exploration, twiddling of the device was noted. Physician explanted the IPG, sensing lead, and a portion of the stimulation lead, and closed. The explant surgery addressed the risk, and the issue is now resolved.

  Patient problems: Twiddlers Syndrome

  MAUDE report 50458208 ↗
• InjuryAug 26, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with a burning and stabbing sensation at the chest incision site. Physician brought the patient into the OR, explanted the IPG and sensing lead, implanted a newer IPG model that does not require a sensing lead, connected the new IPG to the existing stimulation lead, sutured, and closed.

  Patient problems: Burning Sensation

  MAUDE report 50457460 ↗
• InjuryAug 6, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with swelling at the chest incision site. Physician prescribed antibiotics. Patient returned for a follow-up appointment with improvement.

  Patient problems: Swelling/ Edema

  MAUDE report 50164181 ↗
• InjuryAug 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with ongoing pain at the chest and neck implant site since the implant procedure. Physician brought the patient in into the Operating Room, explanted the IPG, implanted a newer IPG model, sutured, and closed.

  Patient problems: Implant Pain

  MAUDE report 50132536 ↗
• InjuryJul 29, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with thinning of the skin at the chest incision site, placing the patient at risk for erosion. Physician brought the patient into the OR and re-sutured the chest incision site. The revision surgery addressed the risk, and the issue is now resolved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50071947 ↗
• InjuryJul 28, 2026Migration

  Patient presented to the physician with movement of the IPG within the pocket, causing pain. Physician brought the patient into the OR, explanted the IPG and sensing lead, implanted a newer IPG model that does not require a sensing lead, sutured, and closed.

  Patient problems: Implant Pain

  MAUDE report 50060145 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with a raised IPG site, redness, warmth, and pain. Due to concern for a possible infection, the physician prescribed antibiotics.

  Patient problems: Erythema; Implant Pain; Inflammation

  MAUDE report 50059985 ↗
• InjuryJul 28, 2026Adverse 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 entire Inspire system.

  Patient problems: Implant Pain

  MAUDE report 50059773 ↗
• InjuryJul 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented to the physician with wound dehiscence at the chest incision site, with visible purulent drainage. Physician obtained cultures and prescribed antibiotics. Physician brought the patient into the OR four days later and noted that the culture results were negative. Physcian performed a washout procedure and closed. Physician obtained a tissue sample for additional culture testing.

  Patient problems: Medical device site infection; Purulent Discharge; Wound Dehiscence

  MAUDE report 50059392 ↗
• InjuryJul 27, 2026Migration

  Patient presented to the physician with movement of the IPG within the pocket, resulting in sharp, stabbing pain that occasionally radiated up the right arm. Physician brought the patient into the OR, securely re-sutured the IPG, and closed.

  Patient problems: Implant Pain

  MAUDE report 50036295 ↗
• InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem

  Patient presented back to the physician with a continued infection at the chest incision site, and the IPG had eroded through the skin. Physician brought the patient into the operating room explanted the IPG and the sensing lead, removed a portion of the stimulation lead, and closed. Postoperative antibiotics were prescribed after the procedure was completed.

  Patient problems: Erosion; Fluid Discharge; Inflammation; Medical device site infection

  MAUDE report 50010131 ↗
• InjuryJun 26, 2026Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH THE IPG FLIPPED ON ITS SIDE WITHIN THE POCKET, POSING A POTENTIAL RISK OF INJURY. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REPOSITIONED AND RE-SUTURED THE IPG, AND CLOSED THE INCISION. THE REVISION SURGERY ADDRESSED THE RISK, AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25638542 ↗
• InjuryJun 26, 2026Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH MOVEMENT AND FLIPPING OF THE IPG WITHIN THE POCKET WHEN LYING ON THE LEFT SIDE, CAUSING PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, RE-SUTURED THE IPG SECURELY, AND CLOSED.

  Patient problems: Pain

  MAUDE report 25637114 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH ITCHINESS AT THE CHEST INCISION SITE AND SIGNIFICANT PAIN. PATIENT ALSO REPORTED PAIN UPON TOUCHING THE SITE AND WHEN MOVING THE RIGHT ARM, WITH PAIN RADIATING TO THE RIGHT SHOULDER. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND EXPLANTED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Implant Pain; Pain; Skin Inflammation/ Irritation

  MAUDE report 25636518 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN IN THE PECTORAL AREA WHERE THE IPG WAS PLACED AND NECK PAIN WHEN TURNING TO THE LEFT. THE PATIENT IS CURRENTLY UNDERGOING PHYSICAL THERAPY FOR TREATMENT.

  Patient problems: Implant Pain; Neck Pain

  MAUDE report 25635800 ↗
• InjuryJun 24, 2026Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH MIGRATION OF THE IPG, WHICH HAD SHIFTED LOWER WITHIN THE POCKET, AND WAS CAUSING PAIN IN THE THROAT, EAR, AND RIGHT SIDE OF THE TONGUE SINCE THE SHIFT. PATIENT ALSO REPORTED THAT THE IPG WOULD FLIP, RESULTING IN A PINCHING SENSATION. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, REPOSITIONED AND RE-SUTURED THE IPG, AND CLOSED.

  Patient problems: Pain

  MAUDE report 25611355 ↗
• InjuryJun 18, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH REDNESS AROUND THE IPG SITE, WHICH WAS SLIGHTLY RAISED. DUE TO A POTENTIAL INFECTION AND SEROMA, THE PHYSICIAN PRESCRIBED ANTIBIOTICS. PATIENT PRESENTED BACK TO THE PHYSICIAN WITH CONTINUED ISSUES AT THE IPG SITE, AND THE WOUND WAS NOT HEALING PROPERLY. NO INFECTION WAS CONFIRMED UPON EXAMINATION. PHYSICIAN OPENED THE CHEST POCKET IN CLINIC, DRAINED THE CLEAR FLUID, PERFORMED A WASHOUT PROCEDURE, AND CLOSED. PHYSICIAN PRESCRIBED AN ADDITIONAL COURSE OF ANTIBIOTICS.

  Patient problems: Fluid Discharge; Impaired Healing; Inflammation; Seroma; Unspecified Infection

  MAUDE report 25554165 ↗
• InjuryJun 17, 2026Expulsion

  PATIENT PRESENTED TO THE PHYSICIAN WITH WOUND DEHISCENCE AT THE CHEST INCISION SITE. UPON EXAMINATION, A SUPERFICIAL INFECTION WAS ALSO SUSPECTED. PHYSICIAN IRRIGATED AND DRAINED THE CHEST INCISION SITE, COVERED THE WOUND, AND PRESCRIBED ANTIBIOTICS. PATIENT PRESENTED BACK TO THE PHYSICIAN WITH CONTINUED WOUND DEHISCENCE AND INFECTION, AND IT WAS NOTED THAT THE IPG WAS BEGINNING TO PROTRUDE THROUGH THE CHEST INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, EXPLANTED THE IPG AND SENSING LEAD, REMOVED A PORTION OF THE STIMULATION LEAD, AND CLOSED. POSTOPERATIVE ANTIBIOTICS WERE PRESCRIBED AFTER THE PROCEDURE WAS COMPLETED.

  Patient problems: Medical device site infection; Pocket Erosion; Wound Dehiscence

  MAUDE report 25535152 ↗
• InjuryJun 5, 2026Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT IPG SITE. UPON EXAMINATION, IT WAS OBSERVED THAT THE IPG HAD MIGRATED MEDIALLY WITHIN THE POCKET AND WAS RUBBING AGAINST THE STERNUM, CAUSING PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REMOVED THE IPG, CREATED A NEW CHEST POCKET, PLACED AND REPOSITIONED THE IPG INTO THE NEW POCKET, SUTURED, AND CLOSED.

  Patient problems: Implant Pain

  MAUDE report 25415223 ↗
• InjuryJun 3, 2026Migration

  FOLLOWING WEIGHT LOSS AND INADVERTENTLY HITTING THE IPG IN THE SHOWER, THE PATIENT PRESENTED TO THE PHYSICIAN WITH IPG MOVEMENT, AS THE DEVICE HAD SHIFTED LOWER WITHIN THE POCKET, POSING A POTENTIAL RISK OF INJURY. UPON EXAMINATION, THE IPG WAS FOUND TO HAVE SLIGHTLY SHIFTED FROM ITS ORIGINAL POSITION. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, RE-SUTURED THE IPG, AND CLOSED. THE REVISION SURGERY ADDRESSED THE RISK, AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25380983 ↗
• InjuryJun 3, 2026Migration

  PATIENT PRESENTED TO THE PHYSICIAN WITH MOVEMENT AND FLIPPING OF THE IPG WITHIN THE POCKET, CAUSING STIMULATION LEAD TETHERING, DISCOMFORT, AND SWELLING AT THE NECK INCISION SITE DOWN TO THE CHEST. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, EXPLANTED THE ENTIRE INSPIRE SYSTEM, IRRIGATED THE IPG POCKET WITH ANTIBIOTIC SOLUTION, AND CLOSED.

  Patient problems: Swelling/ Edema

  MAUDE report 25377635 ↗
• InjuryJun 3, 2026Migration

  AFTER WRESTLING WITH THEIR COLLEGE ROOMMATES, THE PATIENT PRESENTED TO THE PHYSICIAN WITH MOVEMENT AND FLIPPING OF THE IPG WITHIN THE POCKET, RESULTING IN A POTENTIAL RISK OF INJURY. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, RE-SUTURED THE IPG, AND CLOSED. THE REVISION SURGERY ADDRESSED THE RISK, AND THE ISSUE IS NOW RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25377074 ↗

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