Ulthera System Control Unit UC-1 Rev RRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00840763100902), received between Jul 1, 2021 and May 21, 2026 — classified as 6 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Use of Device Problem

  THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US HEALTH CARE PROFESSIONAL AND CONCERNS A FEMALE PATIENT. THE PATIENT WAS TREATED WITH ULTHERAPY ON (B)(6) 2026 IN THE AFTERNOON, FOR CHIN AND JAW LIFT, TARGETING SMAS AND FASCIA. A TOTAL OF 310 LINES WERE APPLIED USING DS 4-4.5MM TRANSDUCERS. THE PATIENT WAS CONCOMITANTLY TREATED WITH SYLFIRM X FOR A MORE SUPERFICIAL TREATMENT TO THE FACE, NECK, FOREHEAD, EYES, LIPS, AND NOSE. AS REPORTED, ABOUT 1025 PULSES WERE APPLIED WITH SYLFIRM X. TREATMENT AREAS WERE MARKED TO ENSURE THE AREAS WERE IN SAFETY ZONES. THIS WAS THE PATIENT'S FIRST EXPERIENCE WITH AESTHETIC TREATMENTS. PATIENT SKINCARE PRODUCTS WERE REPORTED AS NEO FIRM, LUMIERE FIRM, EPIONCE RENEWAL LIGHT MOISTURIZER, AND A GENTLE CLEANSER. CONTROL UNIT, HANDPIECE, AND TRANSDUCER SERIAL NUMBERS USED DURING TREATMENT WERE REPORTED AS (B)(6), RESPECTIVELY. ON (B)(6) 2026, THREE HOURS AFTER TREATMENT WITH ULTHERAPY, THE PATIENT EXPERIENCED SUSPECTED INFLAMMATION ON THE FRONTAL NERVE BRANCH, MUSCLE WEAKNESS ABOVE THE RIGHT EYEBROW/ACUTE DROOPING, ERYTHEMA, AND MILD EDEMA. AFTER ALL TREATMENTS WERE COMPLETED, TOPICAL EXOSOMES WERE APPLIED TO PROMOTE HEALING. THE PATIENT CALLED IN THE AFTER

  Patient problems: Erythema; Muscle Weakness/Atrophy; Nerve Damage; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 25244373 ↗
• InjuryOct 16, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS SPONTANEOUS REPORT RECEIVED FROM A BRAZILIAN AFFILIATE ON (B)(6) 2025 CONCERNS A FEMALE PATIENT OF UNKNOWN AGE. ON (B)(6) 2025, THE PATIENT WAS TREATED WITH THE ULTHERA SYSTEM USING A DS10-1.5 TRANSDUCER FOLLOWING THE EYEBROW LIFT GUIDELINE. DURING TREATMENT, THE PROVIDER ACCIDENTALLY DELIVERED A LINE TO THE RIGHT EYE REGION OF THE PATIENT, CAUSING BLEEDING AT THE TIME AND BLURRED VISION. USE OF LIDOCAINE/ANESTHETIC DURING THE TREATMENT WAS NOT REPORTED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE EVENT WERE MADE (B)(6) 2025. NO ADDITIONAL INFORMATION WAS RECEIVED.

  Patient problems: Blurred Vision; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23315814 ↗
• InjuryNov 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 11-OCT-2024, ULTHERA RECEIVED INFORMATION FROM A BRAZILIAN AFFILIATE VIA EMAIL REGARDING A POTENTIAL ULTHERA ADVERSE EVENT. ACCORDING TO THE REPORT, ULTHERAPY WAS PERFORMED ON A MALE PATIENT, DEMOGRAPHICS UNKNOWN, TO THE MIDDLE THIRD OF THE FACE ON (B)(6) 2024. THE FOLLOWING DAY, (B)(6) 2024, THE PATIENT ALLEGEDLY EXPERIENCED A ¿GRADE 3¿ BURN ON THE LOWER THIRD OF THE LEFT SIDE OF THE FACE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE PATIENT¿S TREATMENT AND PATIENT SYMPTOM RESOLUTION WERE MADE ON (B)(6) 2024. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 20592305 ↗
• InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT WAS RECEIVED FROM A CANADIAN CLINIC PHYSICIAN CONCERNING A FEMALE PATIENT. THE PRACTICE INITIALLY REPORTED ON (B)(6) 2023 A PATIENT RECEIVED AN ULTHERAPY FACE AND NECK TREATMENT ON (B)(6) 2023 AND EXPERIENCED WELTING IMMEDIATELY AFTER TREATMENT. TWO WEEKS LATER, THE MARKS WERE STILL THERE AND CHANGED SLIGHTLY IN COLOR (MORE RED). ON (B)(6) 2024 THE PHYSICIAN PROVIDED AN UPDATE STATING THE PATIENT CAME IN FOR AN APPOINTMENT FOR BOTOX AND REPORTED THE PATIENT HAS TWO RED MARKS UNDER THE JAWLINE LATERALLY ON BOTH SIDES OF HER NECK SINCE ULTHERAPY TREATMENT. THE PATIENT STATED THERE WAS INITIALLY A SWOLLEN BAND ON EACH SIDE FROM ANGLE OF THE JAW TO APPROXIMATELY THE START OF THE MARIONETTE LINE IN THIS AREA. THE SWELLING RESOLVED, BUT THE REDNESS REMAINS ESPECIALLY ON THE LEFT SIDE. THE RIGHT SIDE IS LESS RED AND LOOKS A LITTLE INDENTED. THE LEFT SIDE IS STILL RED, AND SHE FEELS IS STILL A LITTLE SWOLLEN BUT DOES NOT APPEAR INDENTED. THE PHYSICIAN REPORTED IT LOOKS AS IF SHE MAY HAVE A BURN. ON (B)(6) 2024 THE TREATING CLINIC PROVIDED A COMPLETED QUESTIONNAIRE WITH ADDITIONAL INFORMATION RELATED TO TREATMENT ON THIS PATIENT. PER THE QUESTIONNAIRE: THE FULL FACE AND NECK WAS

  Patient problems: Burn(s); Deformity/ Disfigurement; Scar Tissue

  MAUDE report 18727141 ↗
• InjuryJun 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2023, A UNITED KINGDOM HEALTHCARE PROFESSIONAL REPORTED TO A MERZ AFFILIATE CONCERNS REGARDING A PATIENT TREATED WITH ULTHERAPY VIA EMAIL. ACCORDING TO THE REPORT, A PATIENT HAD ULTHERAPY ON THE LOWER FACE AND SUBMENTAL AREA ON (B)(6) 2022. THE PATIENT ALLEGEDLY EXPERIENCED CAT SCRATCH-LIKE SWELLING ON HER FACE FOLLOWING TREATMENT. FOUR MONTHS SINCE TREATMENT, THE CAT SCRATCH-LIKE MARKS SEEM TO BE PITTED SCARS, WHICH WORRIED THE PATIENT. ADDITIONAL INFORMATION REGARDING THE EVENT WAS PROVIDED ON (B)(6) 2023. BASED ON THE INFORMATION PROVIDED, A 32-YEAR-OLD FEMALE PATIENT WAS TREATED WITH 500 LINES DELIVERED USING DS 4.5, DS 3.0, AND DS 1.5 TRANSDUCERS. ULTHERAPY GUIDELINES AND PROTOCOL FROM TRAINING WERE USED. NUMBING CREAM THAT CONTAINS LIDOCAINE WAS USED ON THE PATIENT PRIOR TO TREATMENT. ULTRASOUND GEL WAS USED DURING TREATMENT. IMMEDIATELY POST-PROCEDURE, THE PATIENT EXPERIENCED TENDERNESS AND 3X CAT SCRATCH WELTS WERE IDENTIFIED IN THE AREA. THE PATIENT WAS ADVISED TO MOISTURIZE. THE PATIENT HAD A FACE-TO-FACE REVIEW WITH THE PRACTICE'S MEDICAL TEAM ON (B)(6) 2023. THE CAT-SCRATCHED LOOK WELTS TURNED OUT TO BE IDENTIFIED SCARS. THE SCARS WERE IDENTIFIED IN THE SAME A

  Patient problems: Erythema; Pain; Scar Tissue; Urticaria

  MAUDE report 17054203 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MERZ/ULTHERA RECEIVED INFORMATION FROM A PATIENT ON (B)(6) 2021 REGARDING AN ULTHERA ADVERSE EVENT. THE PATIENT ALLEGED SHE WAS TREATED WITH ULTHERAPY ON (B)(6) 2020 AND (B)(6) 2021. IMMEDIATELY FOLLOWING TREATMENT, THE PATIENT PRESENTED WITH MINOR REDNESS, WHICH RESOLVED WITHIN ONE DAY. THE PATIENT STATED THE TREATMENTS FIRMED HER JAWLINE; HOWEVER, THE PATIENT REPORTS INCREASED LAXITY UNDER HER CHIN AND STATES THAT SHE NOW HAS A "DOUBLE CHIN" WHICH SHE NEVER HAD BEFORE. THE PATIENT CONCLUDED THAT HER ULTHERAPY TREATMENTS DID NOT PROVIDE SATISFACTORY RESULTS. ON (B)(6) 2021, THE PATIENT REPORTED ADDITIONAL INFORMATION, STATING THAT SHE BELIEVES THE TECHNICIAN WHO PERFORMED HER TREATMENT DID IT INCORRECTLY AND ADDED THAT SHE NOW "NEEDS HER NECK DONE." THE PATIENT CLARIFIED THAT SHE BELIEVES SHE REQUIRES SURGERY TO CORRECT THE ISSUE AND REPORTED THAT THE SKIN BEGAN TO SAG ON THE SIDE OF HER NECK. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO GATHER ADDITIONAL TREATMENT DETAILS FROM THE TREATMENT PROVIDER. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Erythema; Unspecified Tissue Injury

  MAUDE report 12104082 ↗