NeuroStar Advanced Therapy System Version 3.8Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00850005944621), received between Jan 23, 2025 and Sep 28, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (3 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. 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 12 most recent of 12 reports, 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 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 27, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  NEURONETICS RECEIVED A MEDWATCH (MW5169286) FROM FDA IN WHICH A PATIENT ALLEGES HE EXPERIENCED A HYPOMANIC EPISODE AFTER HIS 20TH TMS SESSION AT WHICH TIME HIS TREATMENT WAS STOPPED.

  Patient problems: Emotional Changes

  MAUDE report 22088384 ↗
• InjuryMay 16, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A PRACTICE NOTIFIED NEURONETICS THAT A PATIENT EXPERIENCED WORSENING ANXIETY AND RESURFACING OF PTSD IN HER DREAMS AFTER STARTING TMS TREATMENT. SHE STOPPED AFTER 7 TREATMENTS.

  Patient problems: Emotional Changes

  MAUDE report 22036150 ↗
• InjuryJan 23, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  NEURONETICS RECEIVED MEDWATCH (MW) 5163619 FROM FDA VIA EMAIL ON JANUARY 6, 2025. THE MW WAS REPORTED BY THE MOTHER OF A FEMALE PATIENT WHO ALLEGES HEADACHES, DIZZINESS, AND UNSTEADINESS/LEG WEAKNESS AFTER RECEIVING 19 NEUROSTAR ADVANCED THERAPY TMS TREATMENTS. ABOUT A WEEK AFTER THE SYMPTOMS APPEARED THE PATIENT FELL AND WAS TAKEN TO THE ER FOR TESTING.

  Patient problems: Ambulation or Postural Difficulties; Dizziness; Headache

  MAUDE report 21221682 ↗