NeuroStar Advanced Therapy System Version 3.6Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00850005944058), received between Feb 8, 2023 and Feb 3, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• InjuryMay 8, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  A PRACTICE NOTIFIED NEURONETICS THAT A PATIENT STARTED HAVING TREMORS AFTER RECEIVING A FULL COURSE OF TMS TREATMENT.

  Patient problems: Tics/Tremor

  MAUDE report 21984314 ↗
• InjuryMar 27, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  NEURONETICS WAS MADE AWARE BY A TMS PRACTICE THAT A PATIENT EXPERIENCED RIGHT SIDE ARM AND LEG SHAKING AN HOUR AND A HALF FOLLOWING HER 25TH TMS TREATMENT. PATIENT WAS TAKEN TO THE ER AND CONFIRMED TO BE A SEIZURE.

  Patient problems: Convulsion/Seizure

  MAUDE report 21711669 ↗
• InjuryNov 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEURONETICS WAS CONTACTED BY A PROVIDER REPORTING THAT ONE OF THEIR PATIENTS HAD A SEIZURE AFTER COMPLETING HIS FIRST THETA BURST TREATMENT SESSION. EMS WAS CALLED AND THE PATIENT WAS SENT TO THE EMERGENCY ROOM.

  Patient problems: Convulsion/Seizure

  MAUDE report 20599257 ↗
• InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROVIDER'S OFFICE CALLED NEURONETICS TO REPORT THAT THEIR PATIENT'S MOTHER IS CONCERNED THAT THE PATIENT (HER SON) HAS EXPERIENCED A SIGNIFICANT WORSENING IN HIS OCD SYMPTOMS AFTER RECEIVING 16 TREATMENTS. THE PATIENT HAS REPORTEDLY BEEN STAYING UP "ALL NIGHT MAKING LISTS AND CHECKING THEM OVER AND OVER, NOT SLEEPING".

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18836090 ↗
• InjuryAug 28, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  NEURONETICS RECEIVED A CALL FROM A PROVIDER REPORTING THAT ONE OF THEIR PATIENTS EXPERIENCED A SEIZURE DURING THEIR 9TH TREATMENT SESSION AND WAS TAKEN TO THE EMERGENCY ROOM.

  Patient problems: Convulsion/Seizure

  MAUDE report 17631922 ↗
• InjuryFeb 8, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  A TMS PROVIDER CONTACTED NEURONETICS REGARDING A PATIENT WHO REPORTED THE FOLLOWING: "MY BRAIN HAS GONE A BIT WONKY WITH THE TREATMENTS. ABOUT THREE HOURS AFTER TREATMENT, IT'S LIKE A SEISMIC WAVE GOES OFF IN MY BRAIN, AND I'M HIT WITH A WAVE OF DIZZINESS. THE FIRST TWO TIMES IT RESOLVED COMPLETELY. I DID TAKE RELPAX. THE THIRD TIME IT DIDN'T RESOLVE. MY BRAIN HASN'T GONE BACK TO REGULAR VESTIBULAR WISE SINCE MY TREATMENT ON FRIDAY. I HAD A SMALLER WAVE OF OFFNESS/DIZZINESS HIT ME DURING THE TREATMENT AND AFTER THE SEISMIC WAVE LIKE FEELING IN MY BRAIN, IT ESCALATED THAT NIGHT AND STAYED THROUGH THE WEEKEND."

  Patient problems: Dizziness; Headache

  MAUDE report 16326454 ↗