Microneedling devices are among the most widely offered aesthetic treatments in the United States. Powered microneedling devices (FDA product code QAI) and radiofrequency (RF) skin-resurfacing applicators (product code OUH) use arrays of fine needles or electrodes to mechanically puncture or thermally injure the skin, triggering a wound-healing response that can improve texture, acne scars, and fine lines.
The FDA cleared these devices through the 510(k) pathway, which requires a showing of substantial equivalence to a previously cleared device — not new clinical trials. Most patients assume that because a treatment is offered in a medical setting, it has been rigorously tested. The MAUDE (Manufacturer and User Facility Device Experience) database tells a more nuanced story.
An analysis of 66 adverse event reports filed under product codes QAI and OUH in the FDA MAUDE database — received between 2017 and March 2026 — reveals which devices are generating reports, what kinds of injuries are occurring, and how the FDA's October 2025 safety communication on RF microneedling fits into the data.
What the data covers
The MAUDE database contains voluntary and mandatory reports of adverse events involving medical devices. It is a passive surveillance system: it captures only events that are reported to the FDA, not all events that occur. Underreporting is widely acknowledged, and MAUDE data cannot be used to calculate incidence rates.
With that caveat, the 66 reports under QAI and OUH codes break down as follows:
| Metric | QAI (powered microneedle) | OUH (RF skin resurfacing) | Total |
|---|---|---|---|
| Total reports | 58 | 8 | 66 |
| Injury reports | 45 | 7 | 52 |
| Malfunction reports | 13 | 0 | 13 |
| Death reports | 0 | 0 | 0 |
Injury events dominate: 52 of 66 reports (79%) describe patient injuries, ranging from scarring and hyperpigmentation to more serious tissue damage. The remaining 13 reports describe device malfunctions — needles failing to retract, devices firing unexpectedly, or mechanical failures during treatment — without documented patient injury in the report.
Ellacor: the most-reported microneedling device
The Ellacor system with Micro-Coring technology (manufactured by Cytrellis Biosystems, now part of Merz) accounts for 28 of the 58 QAI reports — nearly half the microneedling dataset. Ellacor is distinct from conventional microneedling: instead of solid needles that create narrow puncture wounds, Ellacor uses hollow needles to physically remove micro-cores of skin tissue, aiming to achieve more significant skin tightening and scar improvement.
Of the 28 Ellacor reports:
- 15 are injury reports, concentrated in a 12-month window from March 2023 through December 2023. Reported injuries include scarring, skin irregularities, hyperpigmentation, and uneven appearance between the left and right sides of the treated face.
- 13 are malfunction reports, also concentrated in mid-2023 (May through September 2023). These describe device mechanical issues — needles not deploying correctly, device errors during treatment — that may or may not have resulted in patient injury.
The clustering of Ellacor reports in 2023 is notable. The device received FDA 510(k) clearance (K202517) in July 2021 and launched commercially in 2022, meaning many of these reports came during the early post-market period when providers were learning to use the device. Whether the report volume reflects a genuine safety signal or the typical learning-curve effect of a novel device technology is a question that longer-term surveillance data may clarify.
A peer-reviewed study published in 2022 in Plastic and Reconstructive Surgery — Global Open evaluated Ellacor's safety in 51 patients and found that 89.7% of treated sites showed improvement on the Global Aesthetic Improvement Scale, with patient satisfaction at 85.6% of treatment sites. A separate clinical summary reported that 15.4% of patients experienced erythema or hyperpigmentation lasting more than 4 weeks, and 5.1% experienced temporary focal atrophic scarring — figures that are consistent with the types of events appearing in MAUDE.
SkinPen: rising report volume in 2025–2026
SkinPen (manufactured by Crown Laboratories, formerly Bellus Medical) is the most widely used powered microneedling device in the US and the first microneedling device to receive FDA clearance. It accounts for 12 of the 58 QAI reports.
Unlike Ellacor's concentrated burst, SkinPen reports span from 2022 through early 2026, with a noticeable increase in late 2025:
- 2022: 1 injury report
- 2023: 3 injury reports
- 2024: 3 injury reports
- 2025: 5 injury reports (including one in October and one in December)
- 2026: 2 injury reports (February and March)
The upward trend in 2025 could reflect increased device use, increased awareness of the MAUDE reporting system, or both. The reports describe injuries including scarring, prolonged erythema, and hyperpigmentation.
Other microneedling devices in the data
The remaining QAI reports are distributed across a fragmented landscape of devices, most with only 1–3 reports each:
- Rejuvapen NXT — 3 reports
- Dermapen — 2 reports
- Dr. Pen (a consumer device) — 2 reports
- Plasma pen devices — 2 reports (Louise Walsh Plasma Pen)
- Single-report devices — Micropen EVO, RegenPen, PRX-T33, ZION 7, and others
The presence of consumer devices (Dr. Pen) in the MAUDE data is worth noting. The FDA's October 2025 safety communication explicitly warned that RF microneedling "should not be performed with at-home devices," and classified it as a medical procedure, not a cosmetic treatment.
RF microneedling: the OUH data
Product code OUH covers RF skin-resurfacing applicators — a subset of RF microneedling devices. The 8 reports under this code involve:
- Vivace — 3 reports (RF microneedling device)
- Secret RF — 2 reports
- Virtue RF — 2 reports
- Mediderma Pro RF — 1 report
All 8 reports are injury reports. The small count likely reflects classification rather than absence of events: many RF microneedling devices are classified under broader electrosurgical codes (e.g., GEI for general electrosurgical devices) rather than the specific OUH code. Morpheus8, for example, appears in MAUDE under product code GEI rather than OUH.
How this data fits with the published literature
A 2025 retrospective analysis by researchers at Massachusetts General Hospital and Harvard Medical School (PubMed 41886649) reviewed RF microneedling MAUDE reports from January 2013 through October 2025 and identified 114 reports describing 224 distinct adverse events. Their findings, published in Dermatologic Surgery, showed:
- Textural changes: 56 events (25.0%)
- Pigmentary alteration: 41 events (18.3%)
- Fat loss (lipoatrophy): 26 events (11.6%)
- Inflammatory reactions: 18 events (8.0%)
- Burns: 14 events (6.3%)
- Pain: 12 events (5.4%)
The face, neck, and abdomen were the most commonly treated anatomic regions. Notably, 25.4% of reports occurred in 2023 alone, consistent with the spike visible in our QAI data. Most procedures were performed by unspecified health care professionals (76.3%), while a smaller proportion involved non-clinician operators.
This published study focused specifically on RF microneedling devices and searched MAUDE by brand name, covering products like Morpheus8, Sylfirm X, Secret RF, and Vivace. Our analysis above covers a complementary but different dataset — product codes QAI (powered microneedle devices) and OUH (RF skin resurfacing applicators) — which captures non-RF microneedling devices like Ellacor and SkinPen alongside a subset of RF devices.
The FDA's October 2025 safety communication
On October 15, 2025, the FDA issued a safety communication titled "Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling." The agency stated it was aware of reports of:
- Burns
- Scarring
- Fat loss (lipoatrophy)
- Disfigurement
- Nerve damage
- Cases requiring surgical repair or other medical intervention
The communication specifically listed devices including Profound, Morpheus8, Genius RF, Secret RF, Scarlet RF, Sylfirm X, Potenza, and Pixel 8. It recommended that providers:
- Discuss benefits and risks of all available treatment options with patients
- Emphasize that RF microneedling is a medical procedure, not a cosmetic treatment
- Ensure that treatment should not be performed with at-home devices
- Report adverse events to the FDA through the MedWatch system
The safety communication noted that RF microneedling devices are cleared as Class II medical devices through the 510(k) process, which does not require new clinical trials if a device is substantially equivalent to a predicate device. This means post-market data — including MAUDE reports — are critical for identifying safety issues that may not have been detected in the pre-market phase.
Year-over-year reporting trend
Microneedling device reports in MAUDE show a clear upward trend:
| Year | QAI reports | OUH reports | Combined |
|---|---|---|---|
| 2017 | 0 | 1 | 1 |
| 2020 | 1 | 2 | 3 |
| 2021 | 2 | 1 | 3 |
| 2022 | 7 | 0 | 7 |
| 2023 | 29 | 0 | 29 |
| 2024 | 5 | 0 | 5 |
| 2025 | 11 | 3 | 14 |
| 2026 (Jan–Mar) | 3 | 1 | 4 |
The 2023 spike is driven almost entirely by Ellacor reports (28 of 29 QAI reports that year). Excluding Ellacor, the underlying trend for other microneedling devices still shows a gradual increase, consistent with growing procedure volume.
What patients should know
Microneedling is a medical procedure, not a spa treatment. The FDA's safety communication was explicit about this. Burns, scarring, fat loss, nerve damage, and disfigurement have all been reported. The risk increases with higher energy settings, deeper needle depths, and provider inexperience.
Device matters, but provider matters more. The MAUDE data shows injuries across all major device brands. The common factor in many serious reports is not the device itself but how it was used — energy settings, needle depth, treatment density, and the provider's training with that specific platform.
At-home microneedling carries real risk. Consumer microneedling devices (like Dr. Pen) appear in the MAUDE data. They lack the safety mechanisms, controlled energy delivery, and sterile technique of clinical devices. The FDA has warned specifically against using RF microneedling devices at home.
Ask what device is being used and whether it is FDA-cleared. Not all devices in med-spa settings have FDA clearance. Some clinics use imported or counterfeit devices that lack the quality controls of legitimately cleared products. Patients can verify FDA clearance through the 510(k) database at accessdata.fda.gov.
What to ask before treatment
- Which specific device will be used, and is it FDA-cleared for the planned treatment?
- What training and certification does the provider have on this specific device?
- What needle depth and energy settings will be used, and why those settings were chosen for your skin type and concern?
- What are the realistic recovery expectations, and what should prompt a follow-up call (prolonged redness, new scarring, changes in pigmentation, numbness)?
- Does the clinic have a protocol for managing complications, including access to a supervising physician?
Sources
- FDA MAUDE database — search by product codes QAI and OUH: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/TextSearch.cfm
- FDA Safety Communication: Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling (October 15, 2025): https://www.fda.gov/medical-devices/safety-communications/potential-risks-certain-uses-radiofrequency-rf-microneedling-fda-safety-communication
- FDA MedWatch bulletin on RF microneedling risks: https://content.govdelivery.com/accounts/USFDA/bulletins/3f48263
- Dermatology Times coverage of FDA RF microneedling warning: https://www.dermatologytimes.com/view/fda-alerts-clinicians-to-serious-complications-with-radiofrequency-microneedling-devices
- Gfrerer L, Kilmer SL, Waibel JS, Geronemus RG, Biesman BS. Dermal Micro-coring for the Treatment of Moderate to Severe Facial Wrinkles. Plast Reconstr Surg Glob Open. 2022;10(10):e4547. https://pmc.ncbi.nlm.nih.gov/articles/PMC9575956
- Hashemi DA, et al. Dermal Microcoring for Skin Laxity, Rhytides, and Scars. Dermatol Surg. 2024;50(11S):S135-S138. https://pmc.ncbi.nlm.nih.gov/articles/PMC11556863
- Analysis of US Food and Drug Administration Data on Radiofrequency Microneedling Device Complications. Dermatol Surg. 2025. https://pubmed.ncbi.nlm.nih.gov/41886649
- Ellacor device labeling and contraindications: https://ellacor.com
Analysis sample: FDA MAUDE database extract dated 2026-06-10, 66 adverse event reports under product codes QAI (powered microneedle device, 58 reports) and OUH (RF skin resurfacing applicator, 8 reports), received 2017 through March 2026. Analysis by AestheticMedGuide.
