Evolve System AG608081ARecalls & reported problems
Inmode M.D Ltd · The Evolve System with the T3/Transform Applicator is designed to deliver non-thermal RF energy and electro-muscle and transcutaneous nerve stimulation for the treatment of different body areas for various medical applications. · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07290016633498), received between May 15, 2025 and May 15, 2025 — classified as 2 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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
- Insufficient Device Problem Information2
- Use of Device Problem2
Patient problems
- Full thickness (Third Degree) Burn2
- Partial thickness (Second Degree) Burn2
- Scar Tissue2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 15, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
SECOND DEGREE BURNS ON ABDOMEN FOLLOWING TREATMENT WITH THE TRANSFORM APPLICATOR.
Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn; Scar Tissue
MAUDE report 22025722 ↗InjuryMay 15, 2025Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
SECOND DEGREE BURN ON BUTTOCK FOLLOWING TREATMENT WITH THE TRANSFORM APPLICATOR.
Patient problems: Full thickness (Third Degree) Burn; Partial thickness (Second Degree) Burn; Scar Tissue
MAUDE report 22024215 ↗
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- QB1 NMES System QB-1000-207Motive Health, Inc. · Stimulator, Muscle, Powered1 report
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.