NA 0408660000Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04546540591654), received between Jun 22, 2018 and Jul 29, 2025 — classified as 9 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 29, 2025Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 1 EVENT FOR THE FAILURE: OVERHEATING OF DEVICE. 1 EVENT HAD PROBLEM IDENTIFIED DURING NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22647049 ↗
• MalfunctionOct 28, 2021Fracture; Overheating of Device; Fracture; Overheating of Device

  THIS REPORT SUMMARIZES 3 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED AND CUTTING ACCESSORY FRACTURED. 3 EVENTS HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12715346 ↗
• MalfunctionApr 26, 2021Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 9 MALFUNCTION EVENTS IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 9 EVENTS HAD NO PATIENT INVOLVEMENT. NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11728467 ↗
• MalfunctionOct 28, 2020Overheating of Device; Overheating of Device

  THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE REPORTEDLY OVERHEATED. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10748441 ↗
• MalfunctionNov 28, 2018Fire; Overheating of Device; Smoking; Fire; Overheating of Device; Smoking

  THE USER FACILITY REPORTED THAT WHEN A FLYTE BATTERY WAS CONNECTED TO THE FLYTE HELMET PRIOR TO AN OPERATION, THE BATTERY BEGAN TO SMOKE AND LATER BEGAN TO BURN WITH A SMALL FLAME. THE BATTERY WAS REMOVED FROM THE FLYTE HELMET AND PUT INTO WATER IN A SINK. THE USER FACILITY ALSO REPORTED THAT THE BATTERY WAS DROPPED ON THE FLOOR PRIOR TO CONNECTING THE BATTERY WITH THE HELMET. NO PATIENT INVOLVEMENT WITH THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8112138 ↗
• MalfunctionJun 25, 2018Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED THAT THE DEVICE HEATED UP WHILE TESTING IT AT A FACILITY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7633661 ↗
• MalfunctionJun 25, 2018Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED THAT THE DEVICE HEATED UP WHILE TESTING IT AT A FACILITY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7633582 ↗
• MalfunctionJun 25, 2018Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE REPORTED THAT THE DEVICE HEATED UP WHILE TESTING IT AT A FACILITY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7633581 ↗
• MalfunctionJun 22, 2018Overheating of Device; Overheating of Device

  THE SALES REPRESENTATIVE OBSERVED THAT THE DEVICE HEATED UP DURING TESTING AT THE USER FACILITY. THERE WERE NO REPORTED ADVERSE CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7630108 ↗