NeuroStar Advanced Therapy System 2.XRecalls & reported problems
Neuronetics, Inc. · NeuroStar Mobile Console, recertified · Class 2
All models of NeuroStar Advanced Therapy System (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- 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 00850005944423), received between May 22, 2025 and May 22, 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Patient-Device Incompatibility1
Patient problems
- Headache1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 22, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
PT. EXPERIENCE HEAD PAIN AND EYELID DROOP AFTER 2ND TX. TREATING PHYSICIAN SENT PATIENT TO ER UPON ARRIVAL TO 3RD TX. PT. WAS SUBJECTED TO A CT SCAN (AND ASSOCIATED RISKS WHICH OTHERWISE MAY NOT HAVE REQUIRED). PT. DIAGNOSED WITH COMPLEX MIGRAINES. CAN NOT RULE OUT THAT TMS MAY HAVE CONTRIBUTED TO THE CONDITION AND REQUIREMENT OF DIAGNOSTIC TX. SUBMITTING OUT OF AN ABUNDANCE OF CAUTION.
Patient problems: Headache
MAUDE report 22074764 ↗
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 NeuroStar 2.0 USNeuronetics, Inc. · Transcranial Magnetic Stimulator1 recall2 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
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
- 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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