THERMAGE FLX TR-4Recalls & reported problems
Solta Medical · THERMAGE FLX PATIENT RETURN PAD · Class 1
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00816995021285), received between Apr 19, 2024 and Apr 25, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (3 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method3
- Off-Label Use3
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Burn(s)3
- Scar Tissue3
- Blister1
- Erythema1
- Hyperpigmentation1
- Localized Skin Lesion1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryApr 25, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method
THE PATIENT IS STILL UNDER TREATMENT AT A BURN CLINIC. THE BURN WAS DEEPER THAN EXPECTED, AND TREATMENT HAS NOT YET BEEN COMPLETED. THE PATIENT IS RECOVERING, BUT A PERMANENT SCAR IS EXPECTED. THE DOCTOR CONFIRMED THAT THE RETURN PAD WAS ATTACHED TO THE UPPER BACK. THE RETURN PAD CLIP WAS TOUCHING THE PATIENT''S NECK AND THE BURN WAS NOT IDENTIFIED UNTIL LATE BECAUSE THE PATIENT WAS UNDER GENERAL ANESTHESIA.
Patient problems: Burn(s); Localized Skin Lesion; Scar Tissue
MAUDE report 19184534 ↗InjuryApr 25, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method
THE PATIENT IS STILL UNDER TREATMENT AT A BURN CLINIC. THE BURN WAS DEEPER THAN EXPECTED, AND TREATMENT HAS NOT YET BEEN COMPLETED. THE PATIENT IS RECOVERING, BUT A PERMANENT SCAR IS EXPECTED. THE DOCTOR CONFIRMED THAT THE RETURN PAD WAS ATTACHED TO THE UPPER BACK. THE RETURN PAD CLIP WAS TOUCHING THE PATIENT''S NECK AND THE BURN WAS NOT IDENTIFIED UNTIL LATE BECAUSE THE PATIENT WAS UNDER GENERAL ANESTHESIA.
Patient problems: Blister; Burn(s); Erythema; Scar Tissue
MAUDE report 19182963 ↗InjuryApr 19, 2024Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Improper or Incorrect Procedure or Method; Adverse Event Without Identified Device or Use Problem
THE PATIENT IS STILL UNDER TREATMENT AT A BURN CLINIC. THE BURN WAS DEEPER THAN EXPECTED, AND TREATMENT HAS NOT YET BEEN COMPLETED. THE PATIENT IS RECOVERING, BUT A PERMANENT SCAR IS EXPECTED. THE DOCTOR CONFIRMED THAT THE RETURN PAD WAS ATTACHED TO THE UPPER BACK. THE RETURN PAD CLIP WAS TOUCHING THE PATIENT''S NECK AND THE BURN WAS NOT IDENTIFIED UNTIL LATE BECAUSE THE PATIENT WAS UNDER GENERAL ANESTHESIA.
Patient problems: Burn(s); Hyperpigmentation; Scar Tissue
MAUDE report 19143454 ↗
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- THERMAGE FLX TT0.25F6-450Solta Medical · Massager, Therapeutic, Electric13 reports
- Thermage TTNS3.00E4-900Solta Medical · Massager, Therapeutic, Electric9 reports
- THERMAGE FLX TT4.00F6-600Solta Medical · Massager, Therapeutic, Electric8 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.