NeuroStar Advanced Therapy SystemRecalls & reported problems across all models
Neuronetics, Inc. · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 0
We found 6 models of NeuroStar Advanced Therapy System by Neuronetics, Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Dec 22, 2022 and Sep 28, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (10 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported NeuroStar Advanced Therapy System problems
Device problems
- Adverse Event Without Identified Device or Use Problem17
- Patient-Device Incompatibility10
- Patient Device Interaction Problem9
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- Convulsion/Seizure17
- Headache5
- Emotional Changes4
- Dizziness3
- Tinnitus3
- Anxiety2
- Suicidal Ideation2
- Tics/Tremor2
NeuroStar Advanced Therapy System models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- NeuroStar Advanced Therapy System Version 3.7Transcranial Magnetic Stimulator13 reports
- NeuroStar Advanced Therapy System Version 3.8Transcranial Magnetic Stimulator12 reports
- NeuroStar Advanced Therapy System Version 3.6Transcranial Magnetic Stimulator8 reports
- NeuroStar Advanced Therapy System 3.XTranscranial Magnetic Stimulator3 reports
- NeuroStar Advanced Therapy System 2.XTranscranial Magnetic Stimulator1 report
- NeuroStar Advanced Therapy System Version 3.7Transcranial Magnetic Stimulator1 report
Recent NeuroStar Advanced Therapy System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient experienced a seizure at the very end of his MT determination for TMS treatment, during the final refinement of the power needed for treatment.
Patient problems: Convulsion/Seizure
MAUDE report 50915979 ↗InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem
Patient experienced a seizure while receiving their 27th daily OCD TMS treatment which was part of a composite treatment (MDD (theta burst) and OCD).
Patient problems: Convulsion/Seizure
MAUDE report 50915154 ↗InjurySep 18, 2026Adverse Event Without Identified Device or Use Problem
TMS patient experienced a seizure during a TMS treatment.
Patient problems: Convulsion/Seizure
MAUDE report 50813221 ↗InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem
Dr. (b)(6) called into Neuronetics, Inc. to report that a patient experienced a seizure during TMS treatment a few weeks ago. No information was provided.
Patient problems: Convulsion/Seizure
MAUDE report 50546069 ↗InjuryMar 24, 2026Adverse Event Without Identified Device or Use Problem
A PROVIDER'S NURSE WAS A TRAINING VOLUNTEER FOR DOING A TMS MT. THE INDIVIDUAL ALSO RECEIVED A SINGLE ITBS (TOUCHSTAR THETA BURST) TREATMENT AT 35-50% OF THE DETERMINED POWER FOLLOWING THE MT. ABOUT AN HOUR LATER SHE EXPERIENCED A HEADACHE, DIZZINESS, AND FELT LIKE SHE WAS HAVING AN ANXIETY ATTACK. SHE MISSED TWO DAYS OF WORK INITIALLY BUT ENDED UP MISSING ABOUT 3 WEEKS.
Patient problems: Anxiety; Dizziness; Headache; Unspecified Mental, Emotional or Behavioral Problem
MAUDE report 24675643 ↗InjuryMar 3, 2026Adverse Event Without Identified Device or Use Problem
PATIENT EXPERIENCED A SEIZURE DURING HER 30TH DAILY TREATMENT AFTER RECEIVING 1,907 PULSES. PATIENT WAS TREATED BY EMS AND TAKEN TO THE ER IN STABLE CONDITION.
Patient problems: Convulsion/Seizure
MAUDE report 24503866 ↗InjuryFeb 18, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT'S MOTHER NOTIFIED THE TMS PROVIDER'S PRACTICE THAT HER SON (PATIENT) HAD INFLICTED SELF-HARM BY TAKING TOO MANY PILLS FROM HIS MEDICATION. PATIENT'S MOTHER DID NOT REFER TO IT AS A SUICIDE ATTEMPT BUT REFERRED TO AS SELF-HARM. PATIENT WAS TAKEN TO THE ER AND THEN ADMITTED TO 7 DAYS OF INPATIENT TREATMENT.
Patient problems: Suicidal Ideation
MAUDE report 24385199 ↗InjuryFeb 13, 2026Adverse Event Without Identified Device or Use Problem
PRACTICE REPORTED A FEMALE PATIENT STARTED TO EXPERIENCE NEW ONSET BILATERAL TINNITUS ON (B)(6) 2026 WHILE AT WORK AND AGAIN 2X THAT EVENING. IT OCCURRED FOR THE FIRST TIME DURING TREATMENT ON (B)(6) 2026.
Patient problems: Partial Hearing Loss; Tinnitus
MAUDE report 24339966 ↗InjuryFeb 3, 2026Adverse Event Without Identified Device or Use Problem
THE TREATING PRACTICE CONTACTED NEURONETICS TO INFORM THEM THAT A PATIENT EXPERIENCED A SEIZURE DURING TMS.
Patient problems: Convulsion/Seizure
MAUDE report 24251666 ↗InjuryJan 6, 2026Patient Device Interaction Problem
PATIENT EXPERIENCED A SEIZURE DURING HER 14TH TMS TREATMENT. SHE HAD RECEIVED 27 MINUTES/ 2400 PULSES WHEN SEIZURE ACTIVITY WAS NOTICED. TREATMENT STOPPED AND EMS CALLED.
Patient problems: Convulsion/Seizure
MAUDE report 23977211 ↗InjuryNov 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
PATIENT COMMENTED ON A NNI SOCIAL MEDIA AD THAT HE EXPERIENCED INCREASED ANXIETY AND TICS DUE TO TMS TREATMENT AFTER THE FIRST WEEK OF TREATMENT.
Patient problems: Emotional Changes; Tics/Tremor
MAUDE report 23623996 ↗InjurySep 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NEURONETICS RECEIVED INFORMATION FROM A PRACTICE REGARDING A PATIENT THAT STARTED HAVING PERSISTENT MIGRAINES AFTER TMS TREATMENT NUMBER 17, THE PATIENT WENT TO THE ER TWICE DUE TO THE MIGRAINES BUT THEY WERE UNABLE TO DETERMINE THE CAUSE OR RULE OUT TMS AS THE CAUSE AND REFERRED HER TO A NEUROLOGIST. THE PATIENT REPORTS NOT BEING ABLE TO WORK AS A RESULT OF THE MIGRAINES.
Patient problems: Headache
MAUDE report 23068892 ↗InjurySep 3, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NEURONETICS RECEIVED A REPORT FROM A PRACTICE ALLEGING WORSENING TINNITUS DURING TMS TREATMENT DESPITE WEARING HEARING PROTECTION.
Patient problems: Tinnitus
MAUDE report 22956987 ↗InjuryAug 28, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NEURONETICS RECEIVED A MEDWATCH FROM FDA (MW5173067) ALLEGING THAT NEUROSTAR TMS TREATMENT RESULTED IN WORSENING DEPRESSION AND PERSISTENT INSOMNIA AFTER 1.5 WEEKS OF TREATMENT.
Patient problems: Depression; Sleep Dysfunction
MAUDE report 22919321 ↗InjuryJun 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
PRACTICE CALLED NEURONETICS TO REPORT THAT PATIENT HAD A SEIZURE DURING TREATMENT. PATIENT REFUSED MEDICAL ATTENTION, THE SEIZURE SELF-RESOLVED, AND THEY REPORTED FEELING FINE FOLLOWING THE EVENT.
Patient problems: Convulsion/Seizure
MAUDE report 22367274 ↗
Other Neuronetics, Inc. products
All Neuronetics, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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