Safety Considerations and Complications With Radiofrequency Microneedling: A Cross-Sectional Analysis of the US FDA MAUDE Database.

BACKGROUND

Radiofrequency microneedling (RFMN) is a minimally invasive procedure that promotes skin remodeling and tightening through radiofrequency-generated thermal energy. On October 15, 2025, the US FDA issued a warning on RFMN devices due to reports of serious complications.

OBJECTIVE

To assess the adverse events (AEs) related to commercially available RFMN devices, data were collected from the FDA's manufacturer and user facility device experience (MAUDE) database, which collects medical device reports for suspected injuries.

METHODS

Search query for AEs involving RFMN devices from 2020 to 2025 included search terms for the mechanism of action, brand names, and device manufacturers.

RESULTS

A total of 86 medical device reports associated with RFMN devices were reported in the MAUDE database from 2020 to 2025, with 145 reported AEs. The most reported side effects were fat loss, scarring, and postinflammatory erythema.

CONCLUSION

The MAUDE database serves as a valuable tool for reporting AEs. Adjustment of settings based on the patient and indication as well as real-time device feedback mechanisms can further improve patient safety outcomes.