Inspire 900-007-003Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10855728005465), received between Jul 10, 2018 and Mar 30, 2026 — classified as 45 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 46 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH AN INFECTION AND WAS ADMITTED. IV ANTIBIOTICS WERE ADMINISTERED, AND THE PATIENT WAS ALSO GIVEN ORAL ANTIBIOTICS. UPON EVALUATION, THE INFECTION WAS DETERMINED TO HAVE PROGRESSED TO SEPSIS, RESULTING IN TACHYCARDIA AND PNEUMONIA. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND EXPLANTED THE ENTIRE INSPIRE SYSTEM. PATIENT WILL CONTINUE THE PREVIOUSLY PRESCRIBED COURSE OF ANTIBIOTICS POSTOPERATIVELY.

  Patient problems: Sepsis; Unspecified Infection

  MAUDE report 24719674 ↗
• InjuryMar 9, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN STARTING FROM THE CHEST INCISION SITE THAT RADIATED NEAR THE SENSE LEAD INCISION SITE AND AROUND TO THE BACK. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND EXPLANTED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 24550681 ↗
• InjuryNov 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH A SHOCKING PAIN SENSATION FROM THE GENERATOR, AND THEY WERE ADMITTED AND GIVEN PAIN MEDICATION. PATIENT PRESENTED BACK TO THE PHYSICIAN WITH CONTINUED PAIN AT THE CHEST INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, REPLACED THE IPG AND SENSING LEAD, AND CLOSED.

  Patient problems: Pain

  MAUDE report 23522919 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE CHEST INCISION SITE. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, REPLACED THE IPG, AND CLOSED. THE EXISTING SENSING LEAD WAS ABANDONED AS IT IS NOT USED WITH THE NEW IPG MODEL.

  Patient problems: Pain

  MAUDE report 22808127 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH AN ALLERGY TO TITANIUM AND THROAT DISCOMFORT. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 22637795 ↗
• InjuryApr 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN AT THE CHEST INCISION SITE AND ARMPIT AFTER WEIGHT LOSS. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 21892058 ↗
• InjuryApr 21, 2025Adverse 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 AFTER WEIGHT LOSS. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM, REMOVED THE IPG, CAPPED THE STIMULATION AND SENSING LEAD, AND CLOSED THE SITE.

  Patient problems: Pain

  MAUDE report 21873622 ↗
• InjurySep 14, 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 POCKET. PHYSICIAN BROUGHT THE PATIENT INTO THE OPERATING ROOM AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 20219237 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH THE IPG MOVING IN THE POCKET AND CAUSING PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR, RE-SUTURED THE IPG, AND CLOSED.

  Patient problems: Pain

  MAUDE report 19954075 ↗
• InjuryJul 19, 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 OR, OPENED THE CHEST INCISION, AND FOUND THAT ONE OF THE SUTURES HAD A GRANULOMA DEPOSIT AROUND THE SUTURE. PHYSICIAN FELT THIS WAS THE LIKELY CAUSE OF THE PAIN. PHYSICIAN REMOVED THE SUTURES, RE-SUTURED THE IPG, AND CLOSED.

  Patient problems: Pain

  MAUDE report 19784427 ↗
• InjuryJan 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH PAIN. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND REMOVED THE ENTIRE INSPIRE SYSTEM.

  Patient problems: Pain

  MAUDE report 18515076 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO THE PHYSICIAN WITH A KELOID AT THE CHEST INCISION SITE AND LOOSE IPG CAUSING PAIN IN THE POCKET. PHYSICIAN BROUGHT THE PATIENT INTO THE OR AND CREATED A NEW POCKET AND CLOSED.

  Patient problems: Pain

  MAUDE report 17466577 ↗
• InjurySep 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE POST-TITRATION VISIT, THE PHYSICIAN REPORTED THAT THE PATIENT HAD AN INFECTION. PURULENCE WAS EXPRESSED FROM A 5MM STITCH ABSCESS WHICH WAS JUST INFERIOR TO THE INCISION. THE PATIENT WAS PRESCRIBED KEFLEX FOR 7 DAYS AND THE INFECTION WAS RESOLVED WITH TREATMENT.

  Patient problems: Bacterial Infection

  MAUDE report 9106122 ↗
• InjuryAug 6, 2019Migration; Migration

  THE PATIENT HEARD A ¿POP¿ AND THE IMPLANT BECAME MOBILE. IN A REVISION PROCEDURE ON (B)(6) 2019, THE PHYSICIAN OPENED THE POCKET AND THE IPG WAS RE-SUTURED TO THE RIGHT PECTORALS MAJOR.

  Patient problems: No Code Available

  MAUDE report 8865152 ↗
• InjuryJul 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS INSPIRE PATIENT HAS ALSO HAD A HEART TRANSPLANT AND IS CURRENTLY ON COUMADIN. OVER 5 MONTHS, THE PATIENT WAS SEEN THREE TIMES BY HIS PHYSICIAN FOR PAIN, SWELLING, AND DRAINAGE IN THE AREA OF HIS STIMULATION LEAD NECK INCISION. THE PHYSICIAN CONDUCTED AN ULTRASOUND OF THE AREA AND PRESCRIBED BACTRIM. AT THE SECOND VISIT, THE INCISION APPEARED SLIGHTLY RAISED BUT OTHERWISE OKAY. HOWEVER, THE PHYSICIAN PRESCRIBED ANOTHER ROUND OF BACTRIM OUT OF CAUTION. AT THE NEXT VISIT, THE PHYSICIAN NOTED THAT SWELLING AT THE SITE HAD INCREASED, THERE WAS ALSO DRAINAGE, BUT NO FEVER. THE PHYSICIAN PRESCRIBED ANOTHER ROUND OF BACTRIM AND REFERRED THE PATIENT TO AN INFECTIOUS DISEASE PHYSICIAN. THAT PHYSICIAN CONFIRMED THAT THERE WAS AN INFECTION AT THE STIMULATION LEAD SITE BUT RECOMMENDED A DAILY ANTIBIOTIC FOR LIFE, AND AN ULTRASOUND EVERY 3-4 MONTHS TO ENSURE THAT THE INFECTION IS NOT SPREADING, AS OPPOSED TO EXPLANTING THE SYSTEM.

  Patient problems: Unspecified Infection

  MAUDE report 8798986 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT SUBMANDIBULAR SIALOADENITIS TREATED WITH ANTIBIOTICS.

  Patient problems: Swollen Glands

  MAUDE report 8782847 ↗
• InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT IS EXPERIENCING A FACIAL DROOP ON THE RIGHT SIDE SEVERAL MONTHS AFTER SURGERY.

  Patient problems: Facial Nerve Paralysis

  MAUDE report 8782298 ↗
• InjuryJun 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT PRESENTED WITH SEVERE POST-SURGICAL EAR PAIN WHICH AFFECTED THE PATIENT'S HEARING. THE PHYSICIAN ORDERED ANTIBIOTICS AND EXTENDED THE PATIENT'S POST-SURGICAL STAY IN THE HOSPITAL. THE ISSUE RESOLVED AFTER TREATMENT.

  Patient problems: Hearing Impairment; Pain

  MAUDE report 8718277 ↗
• InjuryJun 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT TREATED WITH AN ANTIBIOTIC (BACTRIM) AND THE INFECTION RESOLVED WITHOUT SURGERY.

  Patient problems: Unspecified Infection

  MAUDE report 8708855 ↗
• InjuryJun 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAIN, SWELLING, FEELING OF HEAT AT IPG SITE REPORTED TO BY THE PATIENT. THE PHYSICIAN PRESCRIBED ANTIBIOTICS ON (B)(6) 2019. SITE DRAINAGE (B)(6) 2019. PAIN, SWELLING AND DRAINAGE UNDETECTABLE AND RESOLVED ON (B)(6) 2019.

  Patient problems: Unspecified Infection

  MAUDE report 8695601 ↗
• InjuryJun 11, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CALLED THE CLINIC ON (B)(6) 2018 WITH COMPLAINTS OF NECK SWELLING AND DIFFICULTY SWALLOWING. THE PHYSICIAN PRESCRIBED A STEROID (MEDROL DOSE PACK) OVER THE PHONE. THE PATIENT CALLED THEIR PHYSICIAN ON (B)(6) 2018 WITH NO RESOLUTION AND CAME TO THE CLINIC. THERE THEY WERE EVALUATED BY A NURSE PRACTITIONER AND FOUND TO HAVE A NECK HEMATOMA. THE PATIENT WAS STARTED ON ANTIBIOTICS TO PREVENT INFECTION. AT POST OP VISIT ON (B)(6) 2018 ISSUE WAS RESOLVED.

  Patient problems: Hematoma

  MAUDE report 8688903 ↗
• InjuryJun 11, 2019Migration; Migration

  DURING A REVISION WHICH WAS INITIALLY INTENDED TO RESTORE THERAPY, THE SURGEON DISCOVERED DEVICE MIGRATION. THE IPG WAS UPSIDE DOWN (I.E., ETCHING DEEP TOWARD THE PECTORALIS MAJOR) UPON FIRST OPENING THE SCAR CAPSULE. THE PHYSICIAN DETERMINED TWIDDLING OF IPG OCCURRED (TWIDDLER'S SYNDROME). NO PRIOR INDICATION FROM THE PATIENT OR PHYSICIAN OF DEVICE MIGRATION. IN THE REVISION, THE SURGEON REPLACED THE IPG AND SENSE LEAD, RESOLVING THE ISSUE. THE IPG WAS ATTACHED WITH WIDE SET ANCHOR POINTS TO PREVENT FUTURE MIGRATION.

  Patient problems: Twiddlers Syndrome

  MAUDE report 8688365 ↗
• InjuryJun 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTS SEVERE NERVE PAIN RADIATING FROM HER NECK TO THE TOP OF HER HEAD AND MIGRAINE HEADACHES. THE PHYSICIAN REPORTS THAT THE PATIENT'S ISSUE IS NOT RELATED TO THE IMPLANT, BUT THAT SOME ASPECT OF THE PROCEDURE TRIGGERED THE PROBLEM AS THERE WAS NO HISTORY PRIOR AND SYMPTOMS STARTED IMMEDIATELY POST-OP IN THE RECOVERY ROOM WHEN SHE WAS COMING OUT OF ANESTHESIA. HER PHYSICIAN HAS NOT ACTIVATED HER DEVICE. THE PHYSICIAN REFERRED THE PATIENT TO A NEUROLOGIST WHO PRESCRIBED MULTIPLE MEDICATIONS FOR SYMPTOM RELIEF AND AN MRI. MRI RESULTS WERE WITHIN NORMAL LIMITS. NEITHER THE NEUROLOGIST NOR THE ENT FEELS THIS IS RELATED TO THE IMPLANT ITSELF, BUT POSSIBLY POSITIONING ON THE TABLE INJURED THE CERVICAL NERVE DURING THE PROCEDURE.

  Patient problems: Neck Pain

  MAUDE report 8683671 ↗
• InjuryMay 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE SURGERY WAS COMPLETED BY DR. (B)(6) ON (B)(6) 2019. THE PATIENT EXPERIENCED A HEMATOMA IN HIS NECK POST-SURGERY. HE CONTINUES TO HAVE SOME SWELLING AND THERE IS A PROMINENT MASS/HEMATOMA AROUND THE INCISION SITE.

  Patient problems: Hematoma

  MAUDE report 8652209 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE TYPE OF REPORTABLE EVENT RECORDED IN BOX H 1 INDICATED DEATH IN THE INITIAL REPORT FOR THIS INCIDENT. THIS WAS IN ERROR, NO PATIENT DEATH OCCURRED.

  Patient problems: Bacterial Infection

  MAUDE report 8537462 ↗

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