NeuroStar Advanced Therapy System 3.XRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00850005944430), received between Jun 15, 2023 and Feb 24, 2025 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED HAVING BALANCE ISSUES AND FALLING 4 TIMES OVER THE PAST 30 DAYS DURING TMS TREATMENT. THE PATIENT WAS NOT SERIOUSLY INJURED DURING THE FALLS, BUT BALANCE ISSUES CONTINUED THROUGHOUT AND AFTER TMS TREATMENT. PATIENT IS SCHEDULED TO SEE A NEUROLOGIST IN THE NEAR FUTURE.

  Patient problems: Balance Problems

  MAUDE report 21446161 ↗
• InjuryJul 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEURONETICS RECEIVED AN EMAIL FROM A TMS PROVIDER INDICATING THAT A PATIENT COMPLAINED OF WORSENING TINNITUS.

  Patient problems: Tinnitus

  MAUDE report 17266345 ↗
• InjuryJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NEURONETICS RECEIVED A CALL FROM A TMS PROVIDER INDICATING THAT A PATIENT WAS HOSPITALIZED FOR DIZZINESS, WEAKNESS AND HEADACHES DURING FIRST WEEK OF TMS TREATMENT. PATIENT DIAGNOSED WITH BENIGN PAROXYSMAL POSTURAL VERTIGO (BPPV).

  Patient problems: Vertigo

  MAUDE report 17137353 ↗