NeuroStar Advanced Therapy System Version 3.7 (REF 81-04315-000)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00850005944522), received between Dec 22, 2022 and Feb 18, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  NEURONETICS RECEIVED INFORMATION FROM THE PARENT OF A NEUROSTAR PATIENT ALLEGING HIS SON HAD WORSENING OCD AND MOTOR TICS AFTER TREATMENT.

  Patient problems: Emotional Changes

  MAUDE report 21935349 ↗
• InjuryNov 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  PROVIDER CONTACTED NEURONETICS TO INFORM THE COMPANY THAT A PATIENT WAS EXPERIENCING AUDITORY HALLUCINATIONS AFTER 16 TMS TREATMENTS.

  Patient problems: Hallucination

  MAUDE report 20738027 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEURONETICS RECEIVED A CALL FROM A PROVIDER REPORTING THAT ONE OF THEIR PATIENTS ATTEMPTED SUICIDE OVER A MONTH AFTER FINISHING HER TMS TREATMENT COURSE AND WAS SUBSEQUENTLY HOSPITALIZED.

  Patient problems: Suicidal Ideation

  MAUDE report 18438485 ↗
• InjuryNov 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROVIDER CONTACTED NEURONETICS TO REPORT THAT ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE IN THE MIDDLE OF THE NIGHT AND WAS SUBSEQUENTLY HOSPITALIZED. PATIENT HAD RECEIVED THEIR 18TH TMS TREATMENT SESSION EARLIER THE SAME DAY THE EVENT OCCURRED.

  Patient problems: Convulsion/Seizure

  MAUDE report 18187409 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEURONETICS RECEIVED A CALL FROM A TMS PROVIDER WHICH REPORTED THAT ONE OF THEIR PATIENTS EXPERIENCING INCREASED ANXIETY WITH TREATMENT.

  Patient problems: Anxiety

  MAUDE report 17452988 ↗
• InjuryMar 3, 2023Use of Device Problem; Use of Device Problem

  TMS PROVIDER CONTACTED NEURONETICS TO INFORM THAT A PATIENT HAD A SEIZURE DURING THEIR 21ST TREATMENT. SEIZURE WAS ESTIMATED TO LAST APPROXIMATELY 4 MINUTES. 911 WAS CALLED AND EMT TRANSPORTED PATIENT TO THE HOSPITAL. THE PATIENT FULLY RECOVERED FROM THE SEIZURE AND WAS RELEASED FROM THE HOSPITAL.

  Patient problems: Convulsion/Seizure

  MAUDE report 16482495 ↗
• InjuryJan 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A PRACTICE CONTACTED NEURONETICS TO REPORT A PATIENT HAD A SEIZURE DURING HER 4TH TMS TREATMENT.

  Patient problems: Convulsion/Seizure

  MAUDE report 16162849 ↗
• InjuryJan 13, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  NEURONETICS, INC. RECEIVED AN EMAIL FROM A CUSTOMER ON (B)(6) 2022 INDICATING THAT A PATIENT HAD A SEIZURE DURING HER 13TH TREATMENT SESSION THAT DAY. THE SEIZURE LASTED ABOUT 35 SECONDS; POST ICTAL LASTED ABOUT 2 TO 3 MINUTES. EMS WAS CALLED BUT THE PATIENT DECLINED TRANSPORT TO THE ER. THE PRACTICE CONFIRMED THAT THE PATIENT SOUGHT EVALUATION BY A NEUROLOGIST AND THAT THE PATIENT CONDITION HAS RETURNED TO NORMAL WITH NO OBSERVED SEQUELAE. THE PRACTICE ALSO CONFIRMED THAT THE PATIENT WAS CONTINUING TREATMENT.

  Patient problems: Convulsion/Seizure

  MAUDE report 16162729 ↗
• InjuryDec 22, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  NEURONETICS, INC. RECEIVED A CALL FROM A COMPANY REPRESENTATIVE THAT ONE OF HIS ACCOUNTS HAD A PATIENT WHO HAD A SEIZURE DURING HIS 10TH TMS TREATMENT SESSION. THE SEIZURE LASTED ONLY 2-3 MINUTES BUT THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM AND HAD A CT SCAN WHICH WAS NORMAL. THE PATIENT WAS DISCHARGED THE SAME DAY AND HAS BEEN DOING WELL WITH NO VISIBLE LASTING ISSUES.

  Patient problems: Convulsion/Seizure

  MAUDE report 16035931 ↗