Ulthera System Control Unit UC-1 Rev. KRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00840763100247), received between Oct 3, 2017 and Jun 23, 2025 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS SPONTANEOUS REPORT RECEIVED FROM A UNITED STATES PATIENT¿S SPOUSE CONCERNS A 52-YEAR-OLD ASIAN, FILIPINO FEMALE PATIENT. ON (B)(6) 2023, THE PATIENT WAS TREATED WITH ULTHERA SYSTEM FOR AN UNKNOWN INDICATION. THE PATIENT WAS NUMBED WITH TOPICAL LIDOCAINE/TETRACAINE 27%/7%. ON AN UNSPECIFIED DATE, POST-TREATMENT WITH ULTHERA SYSTEM, THE PATIENT EXPERIENCED BURN MARKS ON HER FACE IN TWO PLACES (PER REPORT FROM PATIENT'S SPOUSE) AND A BLISTER AND SCAR (REPORTED BY THE TREATMENT SITE). ON (B)(6) 2025, THE PATIENT'S SPOUSE EMAILED STATING: MY WIFE HAD TREATMENTS AT ONE OF YOUR PROVIDERS. THE UL THERAPY BURNED HER FACE IN TWO PLACES. THE PROVIDER HAS TRIED TO MITIGATE THE BURN MARKS, BUT THEY ARE BURNED INTO HER FACE. YOU CAN FEEL AS WELL AS SEE THEM. WE HAVE GOTTEN A SECOND OPINION FROM ANOTHER OF YOUR PROVIDERS. THEY ALL AGREE THAT HER FACE HAS SUFFERED IRREPARABLE DAMAGE AS A RESULT OF YOUR MACHINE NOT FUNCTIONING PROPERLY. THE PATIENT'S SPOUSE EMAILED FOLLOW-UP INFORMATION ON (B)(6) 2025 STATING: THE PROVIDER IS DR. (B)(6). SHE HAS BEEN VERY HELPFUL AND GIVEN FREE TREATMENT TO MY WIFE TO TRY AND MITIGATE THE SCAR. HOWEVER, IT HAS NOT WORKED. FOLLOW-UP INFORMATION WAS RECEIVED FRO

  Patient problems: Burn(s); Pain; Scar Tissue

  MAUDE report 22310240 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MERZ/ULTHERA RECEIVED INFORMATION FROM A PRACTICE ON 05-JAN-2021 REGARDING AN ULTHERA ADVERSE EVENT. THE REPORTER ALLEGED, "WE HAVE A 67-YEAR-OLD FEMALE PATIENT WHO UNDERWENT FULL FACE ULTHERAPY TREATMENT IN (B)(6) 2019 WITH OUR MASTER AESTHETICIAN, (REDACTED) (WHO IS NO LONGER WITH THE COMPANY). THE PATIENT FEELS LIKE SHE HAS EXPERIENCED FACIAL ATROPHY FOLLOWING HER TREATMENT. SHE HAS NEVER HAD COSMETIC FILLERS AND HAS GAINED ABOUT 15 POUNDS IN AN EFFORT TO REGAIN WEIGHT IN HER FACE." THE PRACTICE REPORTED ADDITIONAL INFORMATION ON 26-JAN-2021, STATING THAT THE PATIENT WAS LAST SEEN ON (B)(6) 2020 AND HAS NO ADDITIONAL FOLLOW-UP APPOINTMENTS SCHEDULED. THE REPORTING PHYSICIAN CLAIMED THAT THE PATIENT HAS EXPERIENCED A PROGRESSIVE LOSS OF FACIAL VOLUME OVER THE PAST YEAR FOLLOWING MULTIPLE ULTHERAPY TREATMENTS. THE PATIENT'S HISTORY OF ULTHERAPY TREATMENTS INCLUDE: FULL FACE TREATMENT ON (B)(6) 2019, FULL NECK AND PERIORAL TREATMENT ON (B)(6) 2019, AND REPEAT PERIORAL TREATMENT ON (B)(6) 2019. THE REPORTER ALLEGED THE PATIENT HAS BEEN GAINING WEIGHT IN AN ATTEMPT TO INCREASE FACIAL VOLUME; HOWEVER, THIS HAS NOT HELPED. THE PATIENT HAS NO OTHER MEDICAL PROBLEMS THAT WOULD ATTRIBUTE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Blurred Vision; Bruise/Contusion; Deformity/ Disfigurement; Difficulty Chewing; Dry Eye(s); Headache; Hyperpigmentation; Nervous System Injury; Pain; Paresis; Skin Discoloration; Tissue Breakdown; Vitreous Floaters

  MAUDE report 12909002 ↗
• InjuryAug 20, 2018Off-Label Use; Off-Label Use

  ON (B)(6) 2018, A MERZ AFFILIATE EMAILED TO REPORT THAT A PATIENT EXPERIENCED A BURN ON THE ABDOMEN FOLLOWING AN ULTHERAPY TREATMENT. ON (B)(6) 2018, THE AFFILIATE STATED THAT THE PATIENT MAY NEED A SKIN GRAFT TO RESOLVE THE BURN. THE PATIENT WAS PROVIDED WITH UNKNOWN ANTIBIOTICS AND ANTIPHLOGISTICS (BELIEVED TO REFER TO ANTI-INFLAMMATORY MEDICATION). SUBSEQUENTLY, ON (B)(6) 2018, THE AFFILIATE REPORTED A DIAGNOSIS OF A THIRD DEGREE BURN AND CONFIRMED THE PATIENT HAD UNDERGONE A SKIN GRAFT ON AN UNKNOWN DATE.

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 7799815 ↗
• InjuryMay 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(4) 2018, ULTHERA, INC.,(B)(4) DEVICE INNOVATION CENTER BECAME AWARE VIA EMAIL OF A PATIENT WHO REPORTED DEVELOPING SWELLING AROUND A MENTAL DENTAL IMPLANT FOLLOWING AN ULTHERAPY TREATMENT. THE TREATMENT DATE WAS REPORTED AS (B)(6) 2018 AND THE PATIENT REPORTED THE EVENT TO THEIR TREATING PRACTICE ON (B)(6) 2018. THE PATIENT'S INITIAL REPORT STATED THEY EXPERIENCED WARMTH AROUND THE DENTAL IMPLANT DURING THE TREATMENT, AND THAT TWO DAYS FOLLOWING THE TREATMENT THEY EXPERIENCED FACIAL SWELLING "AND VERY PAINFUL ON DENTAL IMPLANT SIDE." SOME TIME BETWEEN (B)(6) 2018, THE PATIENT WAS PRESCRIBED ANTIBIOTICS PROACTIVELY, AND HAD THE DENTAL IMPLANT REMOVED BY THEIR DENTIST.

  Patient problems: Bruise/Contusion; Edema; Pain

  MAUDE report 7505224 ↗
• InjuryOct 3, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 A MERZ AFFILIATE LOCATED IN (B)(6) REPORTED THAT A FEMALE PATIENT HAD EXPERIENCED SENSORY NERVE PAIN THREE MONTHS POST A FULL FACE ULTHERAPY TREATMENT ADMINISTERED WITH CONTROL UNIT SERIAL NUMBER (B)(4). THE PATIENT WAS TREATED ON (B)(6) 2016 WITH THE STANDARD RECOMMENDED PROTOCOL WITH INCREASED ENERGY. THE PATIENT EXPERIENCED A "SHOCK LIKE SENSATION" ON THE LEFT SIDE OF HER FOREHEAD DURING TREATMENT BUT DID NOT MAKE THE PROVIDER AWARE OF THE PAIN AT THE TIME OF TREATMENT. THREE MONTHS LATER THE PATIENT SOUGHT TREATMENT (PHYSICIAN NAME NOT PROVIDED) FROM A SPECIALIST BECAUSE THE "SHOCK LIKE SENSATION" DID NOT SUBSIDE. THE SPECIALIST DIAGNOSED THE PATIENT WITH TRIGEMINAL NEURALGIA AND PRESCRIBED 300 MG OF GABAPENTIN FOR HER SYMPTOMS. THE AFFILIATE REPORTS THE PATIENT IS 80% RESOLVED.

  Patient problems: Nerve Damage

  MAUDE report 6909733 ↗