Analysis of US Food and Drug Administration Data on Radiofrequency Microneedling Device Complications.

BACKGROUND

Radiofrequency microneedling (RFMN) is increasingly used for rejuvenation, acne scars, and tightening. Although marketed as minimally invasive, lasting adverse effects have been reported. Postmarketing surveillance provides insight into real-world safety.

OBJECTIVE

To characterize adverse events associated with RFMN devices reported to the US FDA MAUDE database, emphasizing the frequency and spectrum of complications.

MATERIALS AND

METHODS

A retrospective review of FDA MAUDE reports from January 2013 to October 2025 was conducted. Entries involving RFMN were analyzed for treatment location and adverse outcomes. Narrative descriptions were categorized into clinically relevant events, and descriptive statistics summarized complication frequencies and anatomic sites.

RESULTS

A total of 114 reports with 224 events were identified. The most frequent complications included textural changes ( n = 56, 25.0%), pigmentary alteration ( n = 41, 18.3%), and fat loss ( n = 26, 11.6%). Inflammatory reactions ( n = 18, 8.0%), burns ( n = 14, 6.3%), and pain ( n = 12, 5.4%) were also frequently reported. The face, neck, and abdomen were the most treated anatomic regions.

CONCLUSION

Although RFMN is generally safe, significant complications may occur. Experience and proper training are crucial to minimizing risks. Clinicians should counsel patients, monitor outcomes, and support surveillance and standardized reporting to improve safety.