NeuroStar TMS Therapy System NeuroStar 2.0 USRecalls & reported problems
Neuronetics, Inc. · . · Class 2
All models of NeuroStar TMS Therapy System (3)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00869378000100), received between Nov 20, 2024 and Jun 30, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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 18, 2026.
Reports received per month
Recalls naming this device
- Aug 24, 2026Open, Classified
Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.
Z-0142-2027 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Patient Device Interaction Problem1
- Patient-Device Incompatibility1
Patient problems
- Convulsion/Seizure1
- Vertigo1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJun 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NEURONETICS RECEIVED A CALL FROM A FORMER TMS PATIENT THAT ALLEGES SHE STARTED HAVING SEIZURES ABOUT 5 MONTHS (MARCH 2025) AFTER HER TREATMENT ENDED IN OCTOBER OF 2024. SHE STATED HER FIRST EPISODES REQUIRED HOSPITALIZATION FOR 3 DAYS.
Patient problems: Convulsion/Seizure
MAUDE report 22366455 ↗InjuryNov 20, 2024Patient Device Interaction Problem; Patient Device Interaction Problem
PRACTICE NOTIFIED A NEURONETICS REPRESENTATIVE THAT A PATIENT WAS EXPERIENCING VERTIGO STARTING AFTER THEIR FIRST TREATMENT. PATIENT'S VERTIGO WOULD INCREASE AS THE %SMT WAS INCREASED SO THEY WERE UNABLE TO GET HIM TO HIS FULL "PRESCRIPTION" STRENGTH. THE VERTIGO AFFECTED THE PATIENT'S DAILY ROUTINE, WORK AND MOOD. VERTIGO COMPLETELY RESOLVED AFTER DISCONTINUING TMS TREATMENT, AFTER THE 12TH TREATMENT, AND THE PATIENT'S MOOD IS COMPLETELY FINE.
Patient problems: Vertigo
MAUDE report 20737983 ↗
Other Transcranial Magnetic Stimulator devices
- NeuroStar TMS Therapy System NeuroStar 3.0 USNeuronetics, Inc. · Transcranial Magnetic Stimulator1 recall58 reports
- NeuroStar Advanced Therapy System Version 3.7Neuronetics, Inc. · Transcranial Magnetic Stimulator1 recall13 reports
- NeuroStar Advanced Therapy System Version 3.8Neuronetics, Inc. · Transcranial Magnetic Stimulator1 recall12 reports
- NeuroStar Advanced Therapy System Version 3.6Neuronetics, Inc. · Transcranial Magnetic Stimulator1 recall8 reports
- NeuroStar TMS Therapy System Upgrade Kit 3.0 USNeuronetics, Inc. · Transcranial Magnetic Stimulator1 recall0 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 Advanced Therapy System Version 3.7Neuronetics, Inc. · Transcranial Magnetic Stimulator1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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