CORE 5400300000Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04546540402035), received between Jul 24, 2018 and Oct 11, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (8 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. 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 11, 2023Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17914861 ↗
• MalfunctionSep 6, 2022Overheating of Device; Overheating of Device

  IT WAS REPORTED THE DEVICE OVERHEATED AND BURNED THE INSIDE OF A PATIENT'S MOUTH DURING A PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 15366184 ↗
• MalfunctionApr 23, 2021Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716018 ↗
• MalfunctionDec 14, 2020Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED DURING TESTING PRIOR TO A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002421 ↗
• MalfunctionDec 14, 2020Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THAT THE DEVICE OVERHEATED. THE PATIENT RECEIVED A SMALL BURN ON THE INSIDE OF THE CHEEK AND THE USER ALSO RECEIVED A SMALL BURN ON THE HAND. NO FURTHER ADVERSE CONSEQUENCES WERE REPORTED.

  Patient problems: Burn(s); No Clinical Signs, Symptoms or Conditions

  MAUDE report 11002409 ↗
• MalfunctionOct 23, 2019Overheating of Device; Overheating of Device

  THE USER FACILITY REPORTED THE DEVICE OVERHEATED DURING A PROCEDURE.  THERE WAS NO PATIENT INVOLVEMENT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9225519 ↗
• MalfunctionOct 29, 2018Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES <NOE> 1 </NOE> MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD NO KNOWN PATIENT INVOLVEMENT OR PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 8013867 ↗
• MalfunctionJul 24, 2018Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. ONE EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT. ONE EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Patient Involvement

  MAUDE report 7714932 ↗