NeuroStar Advanced Therapy System Version 3.7 (REF 81-04315-00R)Recalls & reported problems
Neuronetics, Inc. · NeuroStar Advanced Therapy System, recertified · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850005944829), received between Jun 20, 2025 and Jun 20, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Patient-Device Incompatibility” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Convulsion/Seizure1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 20, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
A PRACTICE NOTIFIED NEURONETICS ON (B)(6) 2025 THAT A PATIENT REPORTED SHE HAD A SEIZURE ON (B)(6) 2025, AT HOME, WHICH OCCURRED DURING HER COURSE OF TMS TREATMENT. THE PATIENT WAS TAKEN TO ER AND RELEASED WITH NO SEQUELAE FROM THE EVENT BUT CHOSE TO DISCONTINUE TMS THERAPY.
Patient problems: Convulsion/Seizure
MAUDE report 22299358 ↗
Other Transcranial Magnetic Stimulator devices
- NeuroStar TMS Therapy System NeuroStar 3.0 USNeuronetics, Inc. · Transcranial Magnetic Stimulator58 reports
- NeuroStar Advanced Therapy System Version 3.7Neuronetics, Inc. · Transcranial Magnetic Stimulator13 reports
- NeuroStar Advanced Therapy System Version 3.8Neuronetics, Inc. · Transcranial Magnetic Stimulator12 reports
- NeuroStar Advanced Therapy System Version 3.6Neuronetics, Inc. · Transcranial Magnetic Stimulator8 reports
- Deep Transcranial Magnetic Stimulation (DTMS) System 104Brainsway Ltd · Transcranial Magnetic Stimulator5 reports
- NeuroStar Advanced Therapy System 3.XNeuronetics, Inc. · Transcranial Magnetic Stimulator3 reports
- NeuroStar TMS Therapy System NeuroStar 2.0 USNeuronetics, Inc. · Transcranial Magnetic Stimulator2 reports
- CloudTMSNeurosoft, Ooo · Transcranial Magnetic Stimulator1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.