Skip to content

Flyte 0408655000Recalls & reported problems

Stryker Corporation · Charger 120V~ 50-60Hz 1.7A · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613154886289), received between Jan 30, 2020 and Jul 26, 2023 — 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

Device problems

  • Overheating of Device2

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Patient Involvement1

Recent adverse event reports

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

  • MalfunctionJul 26, 2023Overheating 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 17397053 ↗
  • MalfunctionJan 30, 2020Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT AT THE USER FACILITY, THE CHARGER OVERHEATED AND THE RUBBER PADS MELTED. THERE WAS NO MEDICAL INTERVENTION AND NO ADVERSE CONSEQUENCES WITH THIS EVENT. AS THIS EVENT OCCURRED DURING INSPECTION AT THE USER FACILITY, THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY TO A SURGICAL PROCEDURE.

    Patient problems: No Patient Involvement

    MAUDE report 9647426 ↗

Other HELMET, SURGICAL devices

All HELMET, SURGICAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.