InMode RF™Recalls & reported problems
Inmode M.D Ltd · InMode RF system · 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 07290016633016), received between Jun 5, 2024 and Jul 21, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Use of Device Problem” (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
- Use of Device Problem2
- Insufficient Device Problem Information1
Patient problems
- Full thickness (Third Degree) Burn1
- Nerve Damage1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 21, 2024Use of Device Problem; Use of Device Problem
FULL THICKNESS BURN ON JOWL.
Patient problems: Full thickness (Third Degree) Burn
MAUDE report 19788435 ↗InjuryJun 5, 2024Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information
NEURAPRAXIA OF THE MOUTH AFTER ACCUTITE PROCEDURE.
Patient problems: Nerve Damage
MAUDE report 19466051 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.