Ulthera System UC-1 Rev 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00840763100476), received between Feb 21, 2017 and Feb 2, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Power Up” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 03-JAN-2024, A MERZ SALES REPRESENTATIVE REPORTED A POTENTIAL ULTHERA ADVERSE EVENT VIA EMAIL. PER THE REPORTING EMAIL, A PATIENT WAS TREATED WITH ULTHERAPY ON THE LOWER FACE ON (B)(6) 2023 AND UNDER THE EYE ON (B)(6) 2023. AT THREE MONTHS POST TREATMENT, THE PATIENT APPEARED TO HAVE KELOID-LIKE SCARRING AS WELL AS ADDITIONAL ISSUES. ON (B)(6) 2024, THE PRACTICE PROVIDED ADDITIONAL TREATMENT INFORMATION RELATED TO THIS PATIENT VIA EMAIL. ACCORDING TO THE PRACTICE, ON (B)(6) 2023 THE PATIENT WAS TREATED ON THE FULL FACE (LOWER FACE, NECK, BROWS, SUBMENTUM) WITH 820 LINES DELIVERED AND ON (B)(6) 2023 30 LINES WERE DELIVERED UNDER THE EYES. THE AREAS WERE REPORTED TO HAVE BEEN TREATED AT DEPTHS OF 1.5MM, 3.0MM, AND 4.5MM USING AQUASONIC CLEAR ULTRASOUND GEL. THE PROVIDER REPORTED BEING UNCERTAIN OF THE TREATMENT GUIDELINE USED OR IF THERE WERE DEVIATIONS FROM THE GUIDELINE. THE ULTHERA DEVICES USED DURING TREATMENT WERE REPORTED TO HAVE PERFORMED AS INTENDED, AND NO MALFUNCTIONS OR DEVICE DEFICIENCIES WERE OBSERVED. THE PATIENT DOES NOT HAVE A HISTORY OF ULTHERAPY TREATMENTS OR OTHER PROCEDURES PERFORMED IN THE AREA. THE PATIENT REPORTEDLY USES SKINCARE PRODUCTS; HOWEVER, THE PRACT

  Patient problems: Burn(s); Localized Skin Lesion; Nodule; Scar Tissue

  MAUDE report 18636742 ↗
• MalfunctionNov 18, 2021Failure to Power Up; Scratched Material; Unintended Electrical Shock; Failure to Power Up; Scratched Material; Unintended Electrical Shock

  ON 22-OCT-2021, A MERZ (B)(4) AFFILIATE REPORTED AN ISSUE WITH AN ULTHERA CONTROL UNIT (CU). ACCORDING TO THE REPORT, "CLINIC WENT TO TURN ON DEVICE, LOUD POP SOUND OCCURRED - SCREEN WOULD NOT SHOW ANYTHING. CAN HEAR CU FANS ON ONLY WHEN HOLDING GREEN BUTTON - WHEN BUTTON IS RELEASED CU COMPLETELY SHUTS OFF. SCREEN DOES NOT HAVE ANY IMAGE AT ALL, FULLY BLACK. NOT ABLE TO PULL SUPPORT LOG AS SCREEN IS NOT OPERATING." DURING FOLLOW UP WITH THE PRACTICE, THE USER STATED SHE PRESSED THE GREEN ON BUTTON IT SHOCKED ME AND HURT HER ARM. THE USER REPORTED THERE WERE NO PHYSICAL INJURIES TO REPORT OTHER THAN HER ARM WAS SORE FROM THE JOLT, AND SHE FULLY RECOVERED THE DAY OF THE INCIDENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Electric Shock; Pain

  MAUDE report 12836238 ↗
• InjuryFeb 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 23, 2016 THE HEALTH CARE PROVIDER REPORTED THAT THEY CONDUCTED AN OFF-LABEL TREATMENT TO THE BACK OF THE PATIENTS LEFT ARM ON (B)(6) 2016 WHICH RESULTED IN THE PATIENT HAVING DIFFICULTY GRIPPING A PIECE OF PAPER IN HER LEFT HAND, AND NUMBNESS/TINGLING ON THAT LEFT ARM AND HAND. SHE STARTED TAKING THE PREDNISONE ON MONDAY (B)(6) 2016 AND AS OF (B)(6) 2016 SAW MARKED IMPROVEMENT.  THE PATIENT WAS ABLE TO GRIP WITH HER LEFT HAND A PIECE OF PAPER BUT STILL COMPLAINED OF WEAKNESS, TINGLING, AND NUMBNESS. THE HEALTH CARE PROVIDER UPDATED TO ULTHERA ON DECEMBER 9, 2016 THAT THE PATIENT IS SEEKING TREATMENT FROM A NERVE SPECIALIST AND REPORTS LIMITED MOBILITY AND SENSATION IN HER LEFT HAND. THE PATIENT WEARS A BRACE AND IS DOING PHYSICAL THERAPY.

  Patient problems: Nerve Damage

  MAUDE report 6345474 ↗