Alma LipoDiode System 1470 110VRecalls & reported problems
Alma Lasers Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 17290110121317), received between Apr 6, 2021 and Jul 14, 2025 — classified as 5 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem4
- Insufficient Device Problem Information1
Patient problems
- Bacterial Infection2
- Breast Discomfort/Pain2
- Burn(s)2
- Sepsis1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IMPORTER REPORTED THAT A PATIENT EXPERIENCED A BURN ON CHIN POST TREATMENT.
Patient problems: Burn(s)
MAUDE report 22501541 ↗InjuryJun 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryFeb 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A USER FACILITY REPORTED THAT A PATIENT DEVELOPED AN INFECTION AT THE TREATMENT SITE FOLLOWING THE USE OF THE ALMA LIPODIODE SYSTEM 1470. AS A RESULT, THE PATIENT WAS HOSPITALIZED FOR THREE DAYS AND REQUIRED A DRAIN TUBE AND IV ANTIBIOTICS FOR TREATMENT.
Patient problems: Sepsis
MAUDE report 21316889 ↗InjuryApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD MEDICAL INTERVENTION FOR A SWOLLEN BREAST.
Patient problems: Bacterial Infection; Breast Discomfort/Pain
MAUDE report 11631570 ↗InjuryApr 6, 2021Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD MEDICAL INTERVENTION FOR A SWOLLEN BREAST.
Patient problems: Bacterial Infection; Breast Discomfort/Pain
MAUDE report 11625033 ↗
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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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