Inspire 900-001-009Recalls & reported problems

Summary

The FDA's MAUDE database contains 125 adverse event reports that list this exact device (DI 10855728005533), received between Aug 26, 2019 and Oct 14, 2022 — classified as 125 injuries.

The most frequently reported specific device problem is “Malposition of Device” (11 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 125 reports, in the reporter's own words as published by the FDA.

• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH NEURAPRAXIA, SLURRED SPEECH, TONGUE SORENESS, INNER EAR PAIN, AND LIMITED MOBILITY OF THE TONGUE. PHYSICIAN PRESCRIBED PAIN MEDICATION.

  Patient problems: Pain

  MAUDE report 15612260 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT, THE PATIENT EXPERIENCED BLEEDING FROM TUNNELING. PHYSICIAN USED CAUTERIZATION AND APPLIED PRESSURE. THIS RESOLVED THE ISSUE.

  Patient problems: Perforation of Vessels

  MAUDE report 15608409 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH AN INFECTION AT THE NECK INCISION. PHYSICIAN PLACED A DRAIN AND TREATED WITH ANTIBIOTICS. PATIENT RETURNED BACK TO THE PHYSICIAN 3 DAYS LATER WITH IMPROVEMENT AT NECK INCISION SITE. PHYSICIAN REMOVED THE DRAIN AND RECOMMENDED PATIENT COMPLETE COURSE OF ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 15582285 ↗
• InjuryOct 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH PAIN FROM NECK INCISION UP TO THEIR LEFT EAR. PHYSICIAN PRESCRIBED PREDNISONE.

  Patient problems: Pain

  MAUDE report 15580259 ↗
• InjuryOct 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH SUSPECTED INFECTION AT THE CHEST AND NECK INCISION. PRIOR TO THE SURGERY THE PATIENT¿S STIMULATION LEAD HAD ERODED THROUGH THE NECK INCISION. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND DETERMINED THERE WAS NO INFECTION AT THE CHEST AND NECK INCISION. PHYSICIAN FLUSHED THE EXPOSED AREA AND SUTURED THE STIMULATION LEAD INTO PLACE. THIS RESOLVED THE ISSUE.

  Patient problems: Erosion

  MAUDE report 15529421 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A REVISION SURGERY, TO RESTORE THERAPY DUE TO A NON-INSPIRE RELATED MEDICAL PROCEDURE WHERE THE STIMULATION LEAD WAS CUT, THE PATIENT EXPERIENCED BLEEDING DURING RE-TUNNELING. PHYSICIAN APPLIED PRESSURE. THIS RESOLVED THE ISSUE.

  Patient problems: Perforation of Vessels

  MAUDE report 15478533 ↗
• InjurySep 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANT PROCEDURE, WHILE USING THE MEDTRONIC CATHETER PASSER, THE PATIENT EXPERIENCED BLEEDING. PHYSICIAN APPLIED DIRECT PRESSURE AND USED CAUTERY TO STOP THE BLEEDING. THIS RESOLVED THE ISSUE.

  Patient problems: Perforation of Vessels

  MAUDE report 15477230 ↗
• InjurySep 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH THE STIMULATION LEAD PROTRUDING FROM THE NECK. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REMOVED THE STIMULATION LEAD, AND PLACED THE PATIENT ON ANTIBIOTICS. THIS RESOLVED THE ISSUE.

  Patient problems: Erosion

  MAUDE report 15428477 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANT PROCEDURE, WHILE USING THE CODMAN CATHETER PASSER, BLEEDING OCCURRED. DIRECT PRESSURE WAS APPLIED TO RESOLVE THE BLEEDING. A FULL PRESSURE DRESSING AT CLOSURE WAS APPLIED. PATIENT PRESENTED WITH HEMATOMA IN THE NECK IN POST-OP. PHYSICIAN BROUGHT THE PATIENT BACK INTO THE OR, DRAINED THE HEMATOMA, AND PACKED IT WITH SURGICEL. THIS RESOLVED THE ISSUE.

  Patient problems: Hematoma; Perforation of Vessels

  MAUDE report 15381485 ↗
• InjurySep 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT, WHILE USING THE MEDTRONIC CATHETER PASSER, IMMEDIATELY AFTER REMOVING THE TUNNELER THERE WAS BLEEDING. DIRECT PRESSURE WAS APPLIED TO STOP THE BLEEDING. THIS RESOLVED THE ISSUE.

  Patient problems: Perforation of Vessels

  MAUDE report 15379736 ↗
• InjurySep 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT, WHILE USING THE MEDTRONIC CATHETER PASSER, A VESSEL WAS NICKED. PHYSICIAN APPLIED DIRECT PRESSURE AND THEN MADE ANOTHER INCISION TO FACILITATE STOPPING THE BLEEDING. THIS RESOLVED THE ISSUE.

  Patient problems: Perforation of Vessels

  MAUDE report 15348105 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING IMPLANT, WHILE USING THE MEDTRONIC CATHETER PASSER, THE EXTERNAL JUGULAR VEIN WAS NICKED. PHYSICIAN APPLIED PRESSURE, USED SUCTION AND A SUTURE TO STOP THE BLEEDING, AND FLUSHED THE AREA WITH SALINE. THIS RESOLVED THE ISSUE.

  Patient problems: Perforation of Vessels

  MAUDE report 15320357 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PHYSICIAN PRESENTED WITH INFECTION AT THE NECK INCISION SITE. PHYSICIAN PRESCRIBED ANTIBIOTICS.

  Patient problems: Unspecified Infection

  MAUDE report 15270247 ↗
• InjuryAug 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANT PROCEDURE, THE MEDTRONIC CATHETER PASSER WAS USED TO TUNNEL THE STIMULATION LEAD AND BLEEDING OCCURRED. PHYSICIAN APPLIED PRESSURE TO STOP THE BLEEDING. THIS RESOLVED THE ISSUE.

  Patient problems: Perforation of Vessels

  MAUDE report 15265305 ↗
• InjuryAug 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN IN THE AREA OF THE JAW AND TETHERING OF THE STIMULATION LEAD. PHYSICIAN SUSPECTED THE PAIN WAS EMANATING FROM THE CUFF LOCATION. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND LOOSENED THE STIMULATION LEAD FROM THE GASTRIC TENDON AND REPOSITIONED THE IPG TO PROVIDE ADDITIONAL SLACK OF THE STIMULATION LEAD UNDER THE SUBMANDIBULAR GLAND. PHYSICIAN ALSO MOVED THE IPG SLIGHTLY MEDIAL AND RESCORED THE POCKET TO PROMOTE HEALING.

  Patient problems: Pain

  MAUDE report 15249055 ↗
• InjuryAug 5, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED WITH ATROPHY OF THE TONGUE TO THE PHYSICIAN. PHYSICIAN ORDERED IMAGING AND OBSERVED THAT THE STIMULATION LEAD APPEARED TO BE PARTIALLY DISLODGED. PHYSICIAN BROUGHT THE PATIENT INTO THE OR TO PERFORM REVISION SURGERY TO RESTORE THERAPY. AT THE REVISION, THE LEADS APPEARED TWISTED UPON ENTERING DUE TO TWIDDLER SYNDROME. THE PHYSICIAN DECIDED TO REMOVE ALL INSPIRE COMPONENTS.

  Patient problems: Twiddlers Syndrome

  MAUDE report 15176406 ↗
• InjuryAug 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH SLURRED SPEECH, MILD HEADACHES, SORE THROAT, AND SUSPECTED NEURAPRAXIA 10 DAYS POST IMPLANT PROCEDURE. PHYSICIAN PRESCRIBED STEROIDS.

  Patient problems: Headache; Speech Disorder

  MAUDE report 15148122 ↗
• InjuryJul 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH NEUROPRAXIA, NECK PAIN, SLURRED SPEECH, AND DIFFICULTY SWALLOWING. PHYSICIAN PRESCRIBED STEROIDS. THIS RESOLVED THE ISSUE.

  Patient problems: Dysphagia/ Odynophagia; Neck Pain

  MAUDE report 15124462 ↗
• InjuryJul 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANT PROCEDURE, THE PATIENT EXPERIENCED BLEEDING. PHYSICIAN USED CAUTERY AND APPLIED PRESSURE TO STOP THE BLEEDING. THIS RESOLVED THE ISSUE.

  Patient problems: Perforation of Vessels

  MAUDE report 15008412 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH REDNESS AND SWELLING AT THE NECK INCISION. PHYSICIAN PRESCRIBED ANTIBIOTICS.

  Patient problems: Swelling/ Edema

  MAUDE report 14981548 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE ER PHYSICIAN WITH EXTREME RIGHT FACIAL PAIN, INNER EAR PAIN, AND POST-AURICULAR PAIN. ER PHYSICIAN RECOMMENDED PAIN MANAGEMENT. IMPLANTING PHYSICIAN PRESCRIBED PAIN MEDS.

  Patient problems: Nerve Damage; Pain

  MAUDE report 14951075 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH THE STIMULATION LEAD COMING OUT OF THEIR NECK. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND PLACED THE STIMULATION LEAD BACK INTO PLACE.

  Patient problems: Erosion

  MAUDE report 14947193 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH THE STIMULATION LEAD ERODING THOUGH THE SKIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND DEBRIDED THE SITE, SCRUBBED THE STIMULATION LEAD WITH BACTISURE, EXCISED AN ELLIPSE OF SKIN AROUND THE EXPOSED LEAD, PERFORMED SUTURE CLOSURE, AND APPLIED SKIN GLUE. PHYSICIAN PRESCRIBED A COURSE OF ANTIBIOTICS AFTER THE PROCEDURE WAS COMPLETED.

  Patient problems: Erosion

  MAUDE report 14859746 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE IMPLANT PROCEDURE, THE MEDTRONIC CATHETER PASSER WAS USED TO TUNNEL THE STIMULATION LEAD AND BREACHED THE EXTERNAL JUGULAR VEIN. PHYSICIAN MADE TWO SEPARATE INCISIONS ALLOWING THEM TO CLIP AND CAUTERIZED THE VEIN. THIS RESOLVED THE ISSUE.

  Patient problems: Perforation of Vessels

  MAUDE report 14847195 ↗
• InjuryJun 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH POTENTIAL NECK INFECTION AND FLUID DRAINING FROM THE SITE. PHYSICIAN PRESCRIBED ANTIBIOTICS. THIS RESOLVED THE ISSUE.

  Patient problems: Unspecified Infection

  MAUDE report 14846360 ↗

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