NA 5400704000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540604132), received between Oct 10, 2019 and Sep 8, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING A PROCEDURE AT THE USER FACILITY THE DEVICE OVERHEATED. NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15382259 ↗
• MalfunctionOct 10, 2019Overheating of Device; Overheating of Device

  IT WAS REPORTED THAT DURING TESTING AT THE USER FACILITY THE DEVICE BECAME QUITE HOT. NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 9175622 ↗