Virtue RFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08800017100715), received between Jan 23, 2026 and Jan 23, 2026 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K150409); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026No Apparent Adverse Event

  ON DECEMBER 30, 2025, CARTESSA AESTHETICS BECAME AWARE OF A REPORTED ADVERSE EVENT SUBMITTED BY A PATIENT, CONVERNING THE SHENB VIRTUE RF MICRONEEDLING DEVICE VIA FDA MEDWATCH REPORT #MW5180017. THE ADVERSE EVENT REPORTED WAS: "VIRTUE RF MICRONEEDLING LEFT ME WITH DEPRESSION SCARS/TRAM TRACK SCARRING." NO INFORMATION ABOUT THE DATE THE REPORTED EVENT OCCURRED, THE SITE WHERE THE REPORTED EVENT TOOK PLACE NOR ANY INFORMATION ABOUT THE NAME OF THE ACTUAL PHYSICIAN WHO PERFORMED THE TREATMENT NOR ANY ID INFORMATION ABOUT THE DEVICE HAS BEEN DISCLOSED IN THE REPORT. A REVIEW OF INTERNAL COMPLAINT LOGS, ADVERSE EVENT LOGS, SERVICE REQUESTS AND EMAILS DID NOT PRODUCE ANY INFORMATION ABOUT THE ACTUAL DEVICE INVOLVED IN THE EVENT NOR ANY INFORMATION ABOUT THE SITE OR ACTUAL PHYSICIAN INVOLVED IN THE EVENT. AS SUCH, WE ARE UNABLE TO INSPECT THE DEVICE NOR CONTACT THE PHYSICIAN THAT PERFORMED THE TREATMENT TO GATHER DETAILS AND FORMALLY INVESTIGATE. WE, THE INITIAL IMPORTER AND DISTRIBUTOR OF THE DEVICE IN THE UNITED STATES, BECAME AWARE OF THE REPORTED EVENT ON DECEMBER 30, 2025, BY EMAIL VIA FDA MEDWATCH REPORT MW5180017. ON DECEMBER 30, 2025, CARTESSA AESTHETICS NOTIFIED THE DEVICE MANUFA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 24164663 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150409. One submission often covers many models, so check the product and lot details in each record.

• Z-0444-2021 · Mar 13, 2020 · Terminated
  SUNG HWAN E&B VIVACE Shenb Innovation of Beauty Technologyt - Product Usage: intended for use in the dermatologic and surgical procedures for electrocoagulation and hemostasis, an