Ulthera System Control Unit PRIME UC-1 Control Unit (PRIME) Rev. ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00840763101145), received between May 16, 2025 and Dec 10, 2025 — classified as 3 injuries, 1 malfunction.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 10, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS SPONTANEOUS REPORT RECEIVED FROM A CUSTOMER CONCERNS A 50+ YEAR OLD, WHITE FEMALE WEIGHING 99 POUNDS. ON (B)(6) 2025, THE PATIENT WAS TREATED WITH ULTHERA PRIME SYSTEM ON THE ENTIRE SUBMENTAL AREA/LOWER FACE DELIVERING 150 TOTAL LINES USING A GREEN TRANSDUCER. THE PATIENT WAS LAST SEEN FOR A FOLLOW UP APPOINTMENT ON (B)(6) 2025. PATIENT HAS NO PRIOR HISTORY OF ULTHERAPY TREATMENTS. PROCEDURES INCLUDED FOUR TREATMENTS OF VIRTUE MICRONEEDLING RF TO FACE AND NECK (MOST RECENTLY IN (B)(6) 2024), MORPHEUS, AND PRX PEELS HAVE PREVIOUSLY BEEN PERFORMED WITHIN THE TREATMENT AREA. THE PRACTICE REPORTED NO MALFUNCTIONS OCCURRED DURING TREATMENT AND THE ULTHERA DEVICES WORKED AS INTENDED. THE PROVIDER REPORTED USING THE RECOMMENDED GUIDELINES FROM ULTHERAPY; HOWEVER, DURING TREATMENT THE USER DEVIATED FROM THE STANDARD GUIDELINES BY MAKING DOUBLE PASSES TO THE SUBMENTAL REGION (DEVICE USE ERROR), ALSO NOTED AS THE UNAFFECTED AREA. TO REDUCE PATIENT DISCOMFORT DURING TREATMENT, PLASTICIZED (REPORTED AS PLASTICIED) NUMBING CREAM (LIDO/TETRA/PE 23/7/2%) WAS APPLIED AND PRONOX WAS USED, NO EPINEPHRINE. ULTRASOUND (US) GEL BY PARKER LABORATORIES WAS USED. SKINCARE PRODUCTS USED BY THE PATIENT

  Patient problems: Inflammation; Scar Tissue; Subcutaneous Nodule

  MAUDE report 23773344 ↗
• MalfunctionSep 8, 2025Smoking; Sparking; Smoking; Sparking

  ON (B)(6) 2025, A SPONTANEOUS REPORT WAS RECEIVED FROM A SALES REPRESENTATIVE ALLEGING A CONTROL UNIT STOPPED MID-OPERATION WITH SPARKS COMING FROM IT. ACCORDING TO THE TREATMENT PROVIDER, THE SPARKS CAME FROM THE GREEN BUTTON (A TINY BIT OF THEM), THEN THE SMOKE CAME OUT AROUND THE GREEN BUTTON. HE TRIED TO RESTART THE CONTROL UNIT AND HEARD A SOUND (UNABLE TO DESCRIBE), NO LIGHT, AND THE SYSTEM WOULD NOT START. NO PATIENT IMPACT WAS ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22994793 ↗
• InjuryJul 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON 04-JUN-2025, AN AUSTRALIAN AFFILIATE REPORTED VIA EMAIL AN ULTHERA ADVERSE EVENT. A 21-YEAR-OLD FEMALE PATIENT RECEIVED ULTHERAPY TREATMENT ON UNKNOWN DATE FOR HER DOUBLE CHIN. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED ACID REFLUX AND VOICE LOSS. AT THE TIME OF REPORTING, MORE THAN EIGHT WEEKS HAD PASSED, AND HER ENT SPECIALIST NOTED THAT THE SYMPTOMS WERE LIKELY TRIGGERED BY THE ULTHERAPY DEVICE. ON 11-JUN-2025, THE AUSTRALIAN AFFILIATE PROVIDED FOLLOW-UP INFORMATION FROM THE ENT SPECIALIST. THE PATIENT WOKE ONE MORNING WITH A COMPLETELY LOST VOICE, ACCOMPANIED BY NAUSEA AND NEUROPATHIC THROAT SYMPTOMS (REFLUX-LIKE). SHE ALSO EXPERIENCED RESTRICTED BREATHING, BURNING IN HER THROAT, AND COUGHING. THE PATIENT HAD NEVER HAD REFLUX SYMPTOMS PRIOR TO THIS INCIDENT. DIAGNOSES INCLUDE VOCAL FOLD PARESIS, ADAPTIVE MUSCLE TENSION DYSPHONIA, AND POSSIBLE LARYNGOPHARYNGEAL REFLUX. FINDINGS SUGGEST A RIGHT ABDUCTION LAG AND A RIGHT BOWED VOCAL FOLD. ON (B)(6) 2025, THE REPORTING SPECIALIST SUSPECTED THAT THE HIGH-FREQUENCY ULTRASOUND TREATMENT MAY HAVE CAUSED NERVE DAMAGE, POTENTIALLY AFFECTING THE VAGUS NERVE. ACTION TAKEN INCLUDED A CONTINUATION OF ANTI-REFLUX MEDICATION WITH THE ADDIT

  Patient problems: Dyspnea; Nerve Damage

  MAUDE report 22469773 ↗
• InjuryMay 16, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS SPONTANEOUS REPORT RECEIVED (B)(6) 2025 FROM A CANADIAN AFFILIATE CONCERNS A 48-YEAR-OLD FEMALE PATIENT. ON (B)(6) 2025, THE PATIENT WAS TREATED ON THE FULL FACE/NECK WITH THE ULTHERA SYSTEM FOR AN ULTRASOUND LIFTING TREATMENT. ON (B)(6) 2025, SEVEN DAYS POST-TREATMENT WITH ULTHERA SYSTEM, THE PATIENT DEVELOPED REDNESS, SWELLING, AND MILD PAIN UNDER THE CHIN (SUBMENTUM - MEDIAL). ON (B)(6) 2025, TEN DAYS POST-TREATMENT, BOTH REDNESS AND SWELLING INCREASED WITH NOTABLE PAIN UPON PALPATION. ON (B)(6) 2025, TWELVE DAYS POST-TREATMENT, THE PATIENT WAS EVALUATED BY THEIR FAMILY PHYSICIAN WHO DIAGNOSED CELLULITIS. MEDICAL CERTIFICATE STATES: SWELLING UNDER CHIN. HR: 70BPM, SUBJECTIVE: ESTHETIC TREATMENT ON THE (B)(6), THEN REDNESS, SWELLING, AND PAIN. [PATIENT] TOOK MOTRIN AND DECREASE A BIT OF SWELLING. NO FEVER. DISCOMFORT WHEN OPENING MOUTH. NO COUGH. NO HEADACHE. OBJECTIVE: EUPNEIC. AFEBRILE. NON-TOXIC REDNESS AND SWELLING, A BIT INDURATION, A SIZE OF AROUND 15 X 18 CM. TEETH PAINLESS. ORAL MUCOSA NORMAL. TONGUE NORMAL. THYROID NORMAL. ASSESSMENT: CELLULITIS PLAN: KEFLEX 500 QID 7 DAYS. FUCIDIN H BID 5 DAYS. CAN CONTINUE IBUPROFEN FOR ANOTHER 1-2 DAYS PRN. ON (B)(6) 2025, FOURTE

  Patient problems: Cellulitis

  MAUDE report 22038030 ↗