DUALTO Energy System ETHCMRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20705036038365), received between Aug 5, 2026 and Sep 11, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Activation, Positioning or Separation 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 11, 2026Computer Software Problem; Device Markings/Labelling Problem

  It was reported that during an unknown procedure the JJI No. 26 communication module is missing its sealing sticker. There was no adverse consequence to the patient.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50733628 ↗
• InjuryAug 14, 2026Arcing of Electrodes; Adverse Event Without Identified Device or Use Problem

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 50255615 ↗
• InjuryAug 5, 2026Activation, Positioning or Separation Problem; Adverse Event Without Identified Device or Use Problem

  It was reported that during an unknown procedure, the patient developed hematoma in their leg following use of the DUALTO device. No additional information was provided regarding the event, severity of the hematoma, or any medical interventions required.

  Patient problems: Hematoma

  MAUDE report 50143855 ↗
• InjuryAug 5, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  Patient problems: Hematoma

  MAUDE report 50142469 ↗