truSculpt iD Hands Free 40Recalls & reported problems
Cutera, Inc. · truSculpt iD Hands Free 40 Handpiece · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816722022462), received between Apr 22, 2019 and Apr 22, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Circuit Failure” (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
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Circuit Failure1
- Electrical Shorting1
Patient problems
- Injury1
- Partial thickness (Second Degree) Burn1
- Patient Problem/Medical Problem1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 22, 2019Circuit Failure; Electrical Shorting; Appropriate Device Problem Term/Code Not Available; Circuit Failure; Electrical Shorting
2 LINEAR BLISTERS ON THE TREATMENT AREA (ABDOMEN). THE HANDPIECE ASSOCIATED WITH THE TREATMENT HAS BEEN RETURNED TO CUTERA FOR COMPREHENSIVE TESTING.
Patient problems: Injury; Partial thickness (Second Degree) Burn; Patient Problem/Medical Problem
MAUDE report 8538173 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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