Ulthera System Transducer UT-4 Rev LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840763100889), received between Jun 6, 2024 and Aug 4, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Off-Label Use” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT RECEIVED FROM AN AUSTRALIAN AFFILIATE CONCERNS A FEMALE PATIENT OF AN UNKNOWN AGE. ON (B)(6) 2025, THE PATIENT WAS TREATED WITH ULTHERA PRIME SYSTEM USING 1.5MM, 3.0, AND 4.5 TRANSDUCERS ON THE FACE. IT WAS ALLEGED THE PATIENT EXPERIENCED LINEAR MARKS OR SKIN DAMAGE TO THE TREATED AREA. ON (B)(6) 2025, AN AUSTRALIAN AFFILIATE REPORTED THE PATIENT WAS INVITED BACK TO THE CLINIC FOR FURTHER EVALUATION, BUT THE PATIENT REFUSED TO RETURN AND IS REQUESTING FINANCIAL COMPENSATION ONLY. IT WAS ALSO REPORTED THE PATIENT CREATED A RED BOOK POST STATING: ¿SYDNEY CITY COSMETIC TREATMENT BURNED MY FACE; A PAINFUL LESSON! I WAS DISFIGURED BY AN ULTHERAPY TREATMENT IN SYDNEY CITY; TWO COSMETIC CLINICS IN SYDNEY COLLUDED TO SCAM PEOPLE! ULTHERAPY BURNS + FALSE ADVERTISING MUST BE EXPOSED! I ORIGINALLY CONSULTED FOR ULTHERAPY AT MISS RIGHT COSMETIC CLINIC IN SYDNEY. THEY PROMISED IN EARLY JUNE THAT THE NEW EQUIPMENT WOULD ARRIVE BY THE END OF JUNE AND TOLD ME TO WAIT FOR MORE INFORMATION.¿ ON 16-JUL-2025, ADDITIONAL INFORMATION WAS RECEIVED. ACCORDING TO THE REPORT: FOLLOWING TREATMENT, THE PATIENT DEVELOPED SECOND-DEGREE BURNS ON THE SKIN UNDER BOTH JAWS, AND A BURN TO THE

  Patient problems: Burn(s)

  MAUDE report 22708044 ↗
• InjuryJun 6, 2024Off-Label Use; Off-Label Use

  ON 18-MAR-2024, A PRACTICE REPORTED VIA EMAIL A POTENTIAL ADVERSE EVENT RELATED TO ULTHERAPY. THE REPORTER STATED: "APPROXIMATELY A MONTH AGO, I TREATED A PATIENT WITH THE ULTHERA LASER, AND POST-TREATMENT, SHE DEVELOPED PROMINENT LINE MARKS ON THE LEFT SIDE OF HER FACE. THE TEXTURED BUMP REMAINS AT THE SITE OF TREATMENT, ALONG WITH A PIGMENTED MARK THAT RESEMBLES A BURN. AS PROVIDER WHO HAS BEEN USING THIS DEVICE FOR YEARS WE HAVE NEVER SEEN SUCH PROLONGED AND SEVERE EFFECTS FROM ULTHERA TREATMENTS BEFORE. OTHER PROVIDERS IN OUR ESTABLISHMENT HAVE ALSO NOTICED A CONCERNING TREND WHERE THE 1.5MM HEADPIECE IS LEAVING INFLAMED LINE MARKS ON PATIENTS, ALTHOUGH THESE TYPICALLY SUBSIDE WITHIN 72 HOURS. THIS RECENT ESCALATION IN ADVERSE REACTIONS IS ALARMING.". ON 22-MAR-2024, THE CLINIC (B)(6) 2024 ON THE LOWER FACE AND SUBMENTAL REGION AT DEPTHS OF 1.5MM AND 3.0MM WITH A TOTAL OF 685 LINES. ALLEGEDLY, THE MARKS STARTED TO PRESENT FOLLOWING USE OF THE 1.5MM TRANSDUCER. THE PATIENT DOES NOT HAVE A HISTORY OF ULTHERAPY TREATMENTS, NOR ANY OTHER PROCEDURES IN THE TREATMENT AREA. THE PATIENT HAD NO SKIN CONDITIONS, HAS FITZPATRICK SKIN TYPE II WITH VERY LIGHT SKIN, NO PIGMENT, AND USES UNKN

  Patient problems: Burn(s); Deformity/ Disfigurement; No Clinical Signs, Symptoms or Conditions; Scar Tissue

  MAUDE report 19481374 ↗