NeuroStar TMS Therapy System NeuroStar 3.0 USRecalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 00869378000117), received between Jun 3, 2022 and Apr 16, 2026 — classified as 58 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (9 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 58 reports, in the reporter's own words as published by the FDA.

• InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT EMAILED THE PRACTICE AND NNI DIRECTLY BUT SEPARATELY REGARDING A VERY LONG LIST OF COMPLAINTS THAT HE FELT ARE RELATED TO TMS TREATMENT. THE PATIENT LISTED A LARGE NUMBER OF ISSUES WHICH WHEN REVIEWED SHOWED A WORSENING OF OCD AND POSSIBLY MDD SYMPTOMS WHICH APPEAR TO HAVE STARTED AFTER HAVING OCD ADDED TO THE MDD TREATMENT.

  Patient problems: Emotional Changes

  MAUDE report 24903600 ↗
• InjuryApr 7, 2026Adverse Event Without Identified Device or Use Problem

  A PATIENT DEVELOPED A SEVERE, PERSISTENT HEADACHE THAT HAS NOW BEEN PRESENT INTERMITTENTLY SINCE (B)(6) 2026.

  Patient problems: Headache

  MAUDE report 24808663 ↗
• InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem

  A PRACTICE REPORTED THAT A CURRENT TMS PATIENT PRESENTED FOR TREATMENT STATING THAT SHE WAS EXPERIENCING NIGHTMARES, VISION DISTORTION, SEEING OBJECTS THAT AREN'T THERE, AND LOUD NOISES BECOMING BOTHERSOME. SHE WANTED TO KNOW IF THESE THINGS WERE COMMON SIDE EFFECTS, WHICH THEY ARE NOT.

  Patient problems: Cognitive Changes; Depression; Dizziness; Fatigue; Hallucination; Headache; Memory Loss/Impairment; Sleep Dysfunction; Unspecified Gastrointestinal Problem; Unspecified Mental, Emotional or Behavioral Problem; Unspecified Nervous System Problem

  MAUDE report 24680807 ↗
• InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem

  THE PROVIDER REPORTED THAT A PATIENT ON THEIR 12TH OCD/MDD TMS SESSION WAS EXPERIENCING BILATERAL HIGH FREQUENCY TINNITUS THAT HAD BEEN UNREMITTING FOR SEVERAL DAYS.

  Patient problems: Tinnitus

  MAUDE report 24378731 ↗
• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT ATTEMPTED SUICIDE IN THEIR HOME. THE PRACTICE NOTED THAT THE PATIENT HAD WORSENING ANXIETY, OCD, AND SUCIDAL IDEATION PRIOR TO THE ATTEMPT, BUT THEIR LAST DEPRESSION SCORES DID NOT WORSEN ABOVE THEIR BASELINE SCORE.

  Patient problems: Convulsion/Seizure

  MAUDE report 24298899 ↗
• InjuryJan 12, 2026Patient-Device Incompatibility

  THE PATIENT NOTIFIED THE TMS PROVIDER'S OFFICE THAT THEY HAVE BEEN EXPERIENCING WORSENING MIGRAINES SINCE ENDING TMS TREATMENT 6 MONTHS AGO.

  Patient problems: Headache

  MAUDE report 24038320 ↗
• InjuryDec 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT COMPLAINED OF HEARING LOSS ABOUT 10 HOURS AFTER RECEIVING HER 5TH TMS TREATMENT. PATIENT WAS NOT OFFERED HEARING PROTECTION AND DID NOT WEAR ANY. ENT DETERMINE THE PATIENT HAD MILD TO MODERATE HEARING LOSS AT TWO FREQUENCIES.

  Patient problems: Partial Hearing Loss

  MAUDE report 23885903 ↗
• InjuryAug 29, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  NEURONETICS RECEIVED A NEGATIVE COMMENT FROM THE COMPANY'S SOCIAL MEDIA MONITOR ALLEGING THAT TMS CAUSED WORSENING TINNITUS.

  Patient problems: Tinnitus

  MAUDE report 22922592 ↗
• InjuryAug 26, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  NEURONETICS RECIEVED INFORMATION FROM A PRACTICE THAT A PATIENT WAS EXPERIENCING WORSENING DEPRESSION, INCREASED IRRITABILITY, AND SUICIDAL IDEATION AFTER TREATMENT SESSION NUMBER 8. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2025 FOR THE SUICIDAL IDEATION.

  Patient problems: Depression; Suicidal Ideation

  MAUDE report 22899690 ↗
• InjuryAug 21, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  NEURONETICS RECEIVED A MEDWATCH FROM FDA (MW5172397) ALLEGING THAT A PATIENT RECEIVED TMS (NEUROSTAR) TREATMENT IN 2023 RESULTED IN RECURRING, UNILATERAL MIGRAINES ON THE SAME SIDE THAT SHE WAS TREATED WITH TMS. ADDITIONALLY, THE PATIENT ALLEGES THAT SHE HAS A TIC ON THE LEFT SIDE OF HER FACE, WHICH IS A COMMON SIDE-EFFECT OF A DRUG SHE WAS TAKING AT THE TIME OF HER TMS TREATMENT. HOWEVER, AFTER STOPPING THE DRUG, THE TIC REMAINED. THE REPORTER STATES THAT SHE "CAN'T CONFIDENTLY ATTRIBUTE ALL THE MIGRAINES TO TMS..." AND THERE IS NO INFORMATION THAT SHE HAS RECEIVED A DIAGNOSIS FROM A NEUROLOGIST.

  Patient problems: Headache; Tics/Tremor

  MAUDE report 22865918 ↗
• InjuryJul 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT REPORTED TO NEURONETICS THAT SHE HAD EXPERIENCED DEBILITATING MIGRAINES, WORSENING DEPRESSION AND SUICIDAL IDEATION AFTER RECEIVING TMS TREATMENTS. THE PATIENT DISCONTINUED TREATMENT AFTER HER 10TH SESSION.

  Patient problems: Emotional Changes; Headache; Suicidal Ideation

  MAUDE report 22571349 ↗
• InjuryJul 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  NEURONETICS RECEIVED AN EMAIL FROM A NEUROSTAR PATIENT THAT REPORTS RINGING IN HER EARS AND HEADACHES AFTER SEVERAL TMS TREATMENT SESSIONS.

  Patient problems: Headache; Tinnitus

  MAUDE report 22570614 ↗
• InjuryJul 10, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEURONETICS WAS MADE AWARE OF NEGATIVE COMMENTS, ON A NEUROSTAR POST, BY THE COMPANY'S SOCIAL MEDIA MONITOR INCLUDING ONE THAT ALLEGED THAT TMS TREATMENT CAUSED (NONSPECIFIC) EYESIGHT ISSUES AND CHRONIC MIGRAINES.

  Patient problems: Headache; Unspecified Eye / Vision Problem

  MAUDE report 22470844 ↗
• InjuryJun 30, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  NEURONETICS WAS MADE AWARE OF NEGATIVE COMMENTS, ON A NEUROSTAR POST, BY THE COMPANY'S SOCIAL MEDIA MONITOR INCLUDING ONE THAT ALLEGED THAT TMS TREATMENT CAUSED ANOSMIA (SENSE OF SMELL LOSS).

  Patient problems: Hyporesponsive to stimuli

  MAUDE report 22353255 ↗
• InjuryMay 25, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  PATIENT ALLEGES THAT TMS TREATMENT HAS AFFECTED HER WALKING AND CAUSED HER TO STUTTER WHICH NEGATIVELY IMPACTS HER ABILITY TO WORK.

  Patient problems: Balance Problems; Speech Disorder

  MAUDE report 22082671 ↗
• InjuryMay 23, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  NEURONETICS RECEIVED INFORMATION FROM A PRACTICE THAT A PATIENT WAS EXPERIENCING WORSENING TINNITUS AFTER STARTING TMS TREATMENT.

  Patient problems: Tinnitus

  MAUDE report 22080058 ↗
• InjuryFeb 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEURONETICS WAS MADE AWARE BY A TMS PRACTICE THAT A MALE PATIENT HAD EYE PAIN AND TWITCHING THAT STARTED ABOUT MIDWAY THROUGH HIS 36 TREATMENT COURSE AND CONTINUES AFTER TREATMENT WAS COMPLETED.

  Patient problems: Eye Pain

  MAUDE report 21463043 ↗
• InjuryJan 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  NEURONETICS RECEIVED MEDWATCH (MW) 5162644 FROM FDA VIA EMAIL ON DECEMBER 9, 2024. IN THE MW A FEMALE PATIENT ALLEGES EMOTIONAL CHANGES AFTER RECEIVING NEUROSTAR TMS TREATMENT. THESE EMOTIONAL CHANGES INCLUDE PARANOIA, ANXIETY, AND FEELING OF ANNOYANCE AND ANGER ALL THE TIME. SHE ALSO ALLEGES FEELING OF "BUGS CRAWLING ON HER SKIN", CONSTANT HEADACHES AND PAINFUL RIGHT HAND AND FOREARM.

  Patient problems: Anxiety; Emotional Changes; Headache; Irritability; Pain; Twitching; Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 21081607 ↗
• InjuryNov 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  A PRACTICE CALLED NEURONETICS TO REPORT THAT A PATIENT HAD A TONIC CLONIC SEIZURE DURING HER FIRST TREATMENT SESSION. THE PATIENT WAS TAKEN TO THE ER AND EXPERIENCED ATRIAL FIBRILLATION WHILE THERE. THE PATIENT WAS UNAWARE OF ANY CARDIAC ISSUES PRIOR TO THIS EVENT. THE PATIENT WILL NOT CONTINUE WITH TMS TREATMENT.

  Patient problems: Atrial Fibrillation; Convulsion/Seizure

  MAUDE report 20738302 ↗
• InjuryNov 13, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PATIENT COMPLAINED OF RINGING IN THEIR EARS DURING AND AFTER TMS TREATMENT. PATIENT HAS NO PRIOR HISTORY OF TINNITUS AND HAS SEEN AN AUDIOLOGIST. PATIENT CLAIMS THIS INTERFERES WITH SLEEP BUT NOT DAILY ACTIVITIES. SYMPTOMS HAVE NOT IMPROVED AT THE TIME OF THIS REPORT.

  Patient problems: Tinnitus

  MAUDE report 20678771 ↗
• InjurySep 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  NEURONETICS WAS CONTACTED BY A PROVIDER WHO CALLED TO ASK WHETHER A PATIENT WHO EXPERIENCED A TIA COULD CONTINUE TREATMENT. ON THE DAY OF HIS 31ST TREATMENT SESSION, THE PATIENT WAS IN A CAR ACCIDENT THAT MORNING BUT HAD COME IN FOR TREATMENT. LATER THAT SAME EVENING, THE PATIENT HAD A TIA.

  Patient problems: Transient Ischemic Attack

  MAUDE report 20257659 ↗
• InjurySep 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEURONETICS RECEIVED A CALL FROM A TREATER REPORTING THAT ONE OF THEIR PATIENTS HAD EXPERIENCED A SEIZURE DURING HER 9TH TREATMENT. THE OFFICE CONTACTED EMS AND THE PATIENT WAS THEN TAKEN TO THE ER.

  Patient problems: Convulsion/Seizure

  MAUDE report 20192878 ↗
• InjuryJun 21, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  NEURONETICS RECEIVED A REPORT FROM A PROVIDER REGARDING A PATIENT WHO DEVELOPED A RETINAL TEAR IN HIS LEFT EYE AFTER RECEIVING 13 TREATMENTS.

  Patient problems: Retinal Tear

  MAUDE report 19584804 ↗
• InjuryJun 11, 2024Use of Incorrect Control/Treatment Settings; Use of Incorrect Control/Treatment Settings

  NEURONETICS WAS CONTACTED BY A PROVIDER THAT REPORTED ONE OF THEIR PATIENTS BECAME NAUSEOUS AND PROCEEDED TO PASS OUT DURING HIS FIRST TREATMENT SESSION. THE TREATER NOTED THAT WHILE THE PATIENT WAS PASSED OUT, HE EXPERIENCED A PERIOD OF "BRIEF SHAKING" BEFORE FALLING "INTO A DEEP SLEEP" AND BEGAN TO SNORE. PATIENT WAS SENT TO THE ER AS A PRECAUTION.

  Patient problems: Nausea; Syncope/Fainting

  MAUDE report 19511418 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEUROMETRICS RECEIVED A CALL FROM A PROVIDER'S OFFICE REPORTING ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE DURING THEIR FIRST TREATMENT SESSION. FOLLOWING THE EVENT, PATIENT WAS TAKEN TO THE EMERGENCY ROOM.

  Patient problems: Convulsion/Seizure

  MAUDE report 19511417 ↗