Ulthera System Transducer UT-3 Rev NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840763100858), received between Sep 30, 2022 and Sep 30, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• InjurySep 30, 2022Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, A PRACTICE REPORTED VIA PHONE A POTENTIAL ULTHERA ADVERSE EVENT. THE PRACTICE STATED: ACCORDING TO THE REPORT, FOLLOWING ULTHERAPY THE PATIENT WAS LEFT WITH A SCAR AND PIGMENTATION ON THE FOREHEAD. THE PRACTICE STATED THAT THE PATIENT EXPERIENCED PAIN, REDNESS, AND SWELLING IMMEDIATELY AFTER TREATMENT. ONCE THE SWELLING WENT DOWN, SHE NOTICED PIGMENTATION AND AN INDENTATION ON THE FOREHEAD. THE PATIENT INITIALLY USED AN OTC SCAR GEL (MEDERMA) TO ATTEMPT TO RESOLVE THE ISSUE. ONCE THE PATIENT NOTICED THE SCAR GEL WAS NOT WORKING, SHE PHONED INTO THE PRACTICE 0N (B)(6) 2022 TO REPORT THE ISSUE. THE PRACTICE PRESCRIBED HTF - 4% HYDROQUINONE, 0.05% RETINOIC ACID, 0.01% FLUOCINOLONE. AS OF (B)(6) 2022, THE RESULT WAS STILL NOT FAVORABLE, AND SCARRING IS DEEP. THE PATIENT WENT TO A DERMATOLOGIST. THE DERMATOLOGIST THE PATIENT SAW RECOMMENDED THE PATIENT GET CO2 LASER TO ADDRESS THE SCAR/INDENTATION, BUT AS OF (B)(6) 2022, THE PATIENT HAS NOT UNDERGONE THIS PROCEDURE. THE PRACTICE STATED THREE TRANSDUCERS WERE USED TO TREAT THE UPPER RIGHT SIDE OF FACE, AND REPORTED NO MALFUNCTIONS OCCURRED WITH THE DEVICES DURING THE TREATMENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT TH

  Patient problems: Burn(s); Skin Discoloration

  MAUDE report 15512290 ↗