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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840763100193), received between Mar 17, 2020 and Dec 3, 2021 — classified as 2 injuries.

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.

• InjuryDec 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29-JUN-2020, ULTHERA RECEIVED INFORMATION FROM A MERZ (B)(6) AFFILIATE REGARDING AN ADVERSE EVENT RELATED TO AN ULTHERAPY TREATMENT PERFORMED ON (B)(6) 2020. THE AFFILIATE REPORTED, "WE HAVE RECEIVED SOME COMPLAINTS OF PATIENT INJURIES." NO ADDITIONAL INFORMATION WAS PROVIDED AT THE TIME. ON 27-OCT-2020, THE AFFILIATE REPORTED ADDITIONAL INFORMATION REGARDING THIS EVENT. ACCORDING TO THE REPORT, "THE PATIENT HAS RECEIVED AN ULTHERAPY FULL FACE AND NECK TREATMENT USING DS4-4.5 AND DS7-3.0 ON (B)(6) 2020. SHE HAD SWELLING AND ERYTHEMA ON HER NECK IMMEDIATELY AFTER THE TREATMENT, BLISTERS APPEARED ON THE NECK ON (B)(6) 2020. THE PATIENT VISITED A DERMATOLOGIST ON (B)(6) 2020, SHE WAS DIAGNOSED BURNT ON THE NECK SKIN DUE TO THE HEAT OF ULTHERA TREATMENT. SOME SECONDARY BACTERIAL INFECTION WAS PRESENTED IN THE AREA WITH YELLOW PUS DOTS. THE DERMATOLOGIST HAS PRESCRIBED BACTROBAN OINTMENT AND ORAL ANTIBIOTICS TO THE PATIENT. UPON FOLLOW UP SESSION WITH THE SAME DERMATOLOGIST ON (B)(6) 2020, THE PATIENT HAD GRADUAL IMPROVEMENT AND WITH THE BLISTERS SUBSIDED, BUT RED SCAR TISSUE APPEARED. THE PATIENT WERE PRESCRIBED SILICONE GEL AND 20% AZELAIC ACID CREAM FOR SCAR AND POST-INFLAMMATORY

  Patient problems: Erythema; Partial thickness (Second Degree) Burn; Pyogenic Infection; Swelling/ Edema

  MAUDE report 12925282 ↗
• InjuryMar 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MERZ/ULTHERA RECEIVED INFORMATION REGARDING AN ULTHERA SYSTEM ADVERSE EVENT VIA LAWSUIT ON 21-FEB-2020. THE REPORTER ALLEGED THAT SHE SUSTAINED SERIOUS INJURIES AS A RESULT OF HER ULTHERA TREATMENT PERFORMED ON (B)(6) 2019. POST TREATMENT, THE PATIENT STATED THAT ULTHERAPY CAUSED HER SEVERE AND PERMANENT FACIAL, EYE, AND NERVE DAMAGE, INCLUDING TINGLING IN THE RIGHT ARM AND LEG, PARESTHESIA, BILATERAL UNCONTROLLED HAND SHAKING, FACIAL NUMBNESS, FACIAL PAIN, FAT ATROPHY, INCREASED WRINKLES, VISION LOSS, BLURRED VISION, EYE HEMORRHAGE, RINGING OF THE EARS, LIGHT SENSITIVITY, ORAL DRYNESS AND ASSOCIATED MOUTH AND TEETH PAIN, INCREASED SKIN ELASTICITY, AND OTHER PAINFUL, DISFIGURING, DEBILITATING INJURIES THAT WERE NOT SPECIFIED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Blurred Vision; Eye Injury; Loss of Vision; Nerve Damage; Numbness; Pain; Shaking/Tremors; Tingling; Tinnitus; Tissue Damage; Visual Impairment

  MAUDE report 9843370 ↗