Safety Considerations and Complications With Radiofrequency Microneedling
A Cross-Sectional Analysis of the US FDA MAUDE Database.
Camacho-Hubbard I, Ibrahimi OA, Mariwalla K, Munavalli G
Dermatologic SurgeryIn the feed 10 Jul 2026, published online 7 Jul 2026, issue 2026 Sep 01, added to PubMed 10 Jul 2026
Topics: Wounds & scarsCosmetic & skin careLasers & devices
Abstract
BACKGROUNDRadiofrequency 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.
OBJECTIVETo 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.
METHODSSearch query for AEs involving RFMN devices from 2020 to 2025 included search terms for the mechanism of action, brand names, and device manufacturers.
RESULTSA 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.
CONCLUSIONThe 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.
Abstract from PubMed
PMID 42430734 · DOI 10.1097/DSS.0000000000005251