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

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840763100216), received between Oct 17, 2017 and Jan 11, 2024 — classified as 3 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 11, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ON 13-DEC-2023, A MERZ PRODUCT DEVELOPMENT SPECIALIST (PDS) REPORTED VIA PHONE THAT ON (B)(6) 2023 A PATIENT EXPERIENCED AN ADVERSE EVENT. THE PDS STATED: "[PATIENT] RECEIVED SWELLING/BURNS ON THE NECK, FACE, AND MOUTH, AS WELL AS NERVE DAMAGE, NUMBNESS, AND SHOOTING PAINS TO THE TOP OF THE HEAD. PATIENT ALSO EXPERIENCING SKIN HYPERSENSITIVITY." TEXT MESSAGES FROM THE TREATING PHYSICIAN WERE ALSO RECEIVED ON 13-DEC-2023. THE PHYSICIAN STATED: "[PATIENT] HAS SWELLING AND BURNS ON THE FACE, NECK, AND INSIDE THE MOUTH [THAT] ARE EXTENSIVE. I WILL ARRANGE FOR FORMAL PHYSICAL EXAMINATION BY INDEPENDENT PRACTITIONER AS WELL AS NEUROLOGIST SINCE [PATIENT] HAS NUMBNESS IN PARTS OF HER FACE, PARESTHESIAS, DYSESTHESIAS, SHOOTING PAINS TOWARD THE TOP OF HER HEAD, AND HYPERSENSITIVE SKIN IN OTHER AREAS." ON 21-DEC-2023, MERZ PRODUCT SAFETY PROVIDED AN EMAIL UPDATE. PER THE EMAIL, THE TREATING PHYSICIAN REPORTED VIA PHONE (ON (B)(6) 2023) THAT: "[PATIENT] IS EXPERIENCING SIGNIFICANT NERVE SENSITIVITY. THIS HAS PERSISTED FROM THE NIGHT OF (B)(6) 2023 TO PRESENT WITH NO SIGNS OF IMPROVEMENT. [PATIENT] HAD A FULL FACE AND NECK TREATMENT AND OPTED FOR NO PAIN MANAGEMENT. PAIN DURING TREATMENT WAS D

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Burn(s); Deformity/ Disfigurement; Headache; Nerve Damage; Pain; Salivary Gland Problem; Scar Tissue; Skin Discoloration; Skin Infection; Swelling/ Edema; Urticaria

  MAUDE report 18498380 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 29-AUG-2022, A MERZ RUSSIA AFFILIATE REPORTED VIA EMAIL OF A POTENTIAL ULTHERA ADVERSE EVENT. THE AFFILIATE STATED: "ON (B)(6) THE PATIENT I.O.V. (37 YEARS OLD) HAD TREATMENT WITH ULTHERA PROCEDURE (5 PLUS PROTOCOL). PHOTOS BEFORE AND AFTER PROCEDURE WAS NOT TAKEN. THE KETANOV WAS GIVEN BEFORE THE PROCEDURE. AFTER ULTHERA PROCEDURE THE PATIENT HAD DISPORT PROCEDURE (60 UNITS). A WEEK LATER THE PATIENT INFORMED THE PHYSICIAN ABOUT NUMBNESS ON THE FACE. DUE TO THE PATIENT'S LOCATION IN SPAIN FOR THAT TIME IT WAS NOT POSSIBLE FOR THE PHYSICIAN TO EXAMINE HER. THE PHYSICIAN EXPLAINED VIA THE PHONE CALL THAT SUCH HP (NUMBNESS) IS POSSIBLE AND ASKED TO BE IN TOUCH. ON AUGUST, 18, THE PATIENT INFORMED THE PHYSICIAN THAT SHE IS IN CLINIC CAUSE OF DIFFICULTY IN BREATHING, TONGUE EDEMA AND NASAL CONGESTION. ON MRI AND CT THERE WAS NOT FOUND ANY PATHOLOGY; REFLEXES ARE NORMAL. THE PHYSICIAN ASKED THE PATIENT THE MRI AND KT CONCLUSION AND ALSO SUGGESTED TO HAVE A CONSULTATION WITH NEUROLOGIST ONLINE. THE PATIENT HASN'T ANSWERED TO THE PHYSICIAN FOR THE PRESENT TIME." ADDITIONAL TREATMENT INFORMATION WAS RECEIVED FROM THE MERZ RUSSIA AFFILIATE ON (B)(6) 2022. ACCORDING TO THE PHYSICIAN, THIS

  Patient problems: Dyspnea; Neuropathy; Swelling/ Edema

  MAUDE report 15512248 ↗
• InjuryOct 17, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, A MERZ FIELD REPRESENTATIVE WAS MADE AWARE VIA A PHONE CALL FROM A TREATMENT PROVIDER THAT A PATIENT HAD A HYPERTROPHIC SCAR IN THE SHAPE OF ONE LINE ON THE LATERAL UPPER NECK FOLLOWING AN ULTHERA TREATMENT. THE FULL FACE ULTHERA TREATMENT OCCURRED ON (B)(6) 2016. THE SERIAL NUMBER OF THE DEVICE WAS OBTAINED FROM CUSTOMER RECORDS. ON (B)(6) 2017, THE PATIENT INFORMED HER ULTHERA PROVIDER THAT SHE HAD A HYPERTROPHIC SCAR. THE DOCTOR RECOMMENDED A SILICONE STRETCH SHEET BAND-AID AT THAT TIME. ON (B)(6) 2017, THE PATIENT HAD A FOLLOW UP APPOINTMENT DURING WHICH THE PROVIDER DETERMINED THAT THE SCAR WAS WORSENING AND EXTENDING, TURNING INTO A KELOID SCAR. THE PROVIDER EXCISED THE HYPERTROPHIC SCAR ON THAT DAY.

  Patient problems: Scar Excision; Scarring

  MAUDE report 6957084 ↗