InModeRF hand piece HP1022B6ARecalls & reported problems
Inmode M.D Ltd · Fractional RF Quantum Handpiece which comprises canula with active electrodes, handle, cable and connector Handpiece HP1022B6A has a canula diameter of 2mm and 10cm long. Maximal RF power is 35W. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07290019863069), received between Dec 16, 2025 and Dec 16, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device Problem” (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.
Reports received per month
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Nerve Damage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryDec 16, 2025Use of Device Problem; Use of Device Problem
TREATMENT PROVIDER REPORTED OF A FEMALE PATIENT SUSTAINING NEURAPRAXIA OF THE BUCCAL BRANCH OF THE FACIAL NERVE 5 DAYS POST QUANTUM RF PROCEDURE, MANIFESTED AS "DIFFICULTY WITH DRINKING FROM A STRAW, SOME DIFFICULTY WITH BRUSHING HER TEETH AND SOME ISSUES WITH WORD ENUNCIATION. ". ON THE PROVIDED PHOTOS, AN ELDERLY FEMALE PATIENT PRESENTED AN ASYMMETRICAL SMILE, WITH THE LEFT SIDE NOT CONTRACTING UPWARDS.
Patient problems: Nerve Damage
MAUDE report 23815214 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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