Integra® 001388LX9Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10381780168034), received between Dec 16, 2021 and Dec 31, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (4 reports).

8 other recalls cover devices cleared under the same FDA submission (K864380); they may or may not involve this specific model.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Overheating of Device; Overheating of Device

  THIS IS 1 OF 2 REPORTS FOR THE 1ST DEVICE REPORTEDLY USED DURING THIS EVENT. THIS REPORT IS LINKED TO MFG# 3006697299-2026-00015.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934205 ↗
• MalfunctionNov 10, 2024Material Fragmentation; Overheating of Device; Material Fragmentation; Overheating of Device

  IT WAS REPORTED THAT DURING A SPINAL FUSION PROCEDURE, THE GLASS SHATTERED ON THE UL PRO FUSED HEADLIGHT CABLE 9FT (001388LX9) CONNECTION TO THE MLX LIGHT SOURCE. "IT WAS VERY HOT AND CHARRED THE SURGEON'S SURGICAL GOWN." IT WAS REPORTED THAT THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT AND NO INJURY OR SURGICAL DELAY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20649471 ↗
• MalfunctionMar 15, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918835 ↗
• MalfunctionMar 15, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18918822 ↗
• MalfunctionJun 19, 2023Overheating of Device; Overheating of Device

  A FACILITY REPORTED THAT DURING PREPARATION/INSPECTION BEFORE SURGERY, THE UL PRO FUSED HEADLIGHT CABLE 9FT (001388LX9) END FITTING GREW EXTREMELY HOT AND MELTED PART OF THE SHEATH DOWN. THE CABLE WAS REPORTEDLY USED WITH INTEGRA MLXEU UNIT, WITH LIGHT INTENSITY OF 90%. THERE WAS NO PATIENT CONTACT; THUS, NO INJURY OR SURGICAL DELAY WAS REPORTED. END USER FACILITY: (B)(6) HOSPITAL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17159896 ↗
• MalfunctionJun 21, 2022Overheating of Device; Smoking; Overheating of Device; Smoking

  A FACILITY REPORTED THAT UPON FIRST USE, THE CUSTOMER PLUGGED THE UL PRO FUSED HEADLIGHT CABLE 9FT (001388LX9) INTO THE LIGHT SOURCE AND A LOUD ¿POP¿ WAS HEARD. FOLLOWING THE POP, SMOKE BEGAN TO RISE FROM THE CABLE. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT INJURY OR SURGICAL DELAY HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14760546 ↗
• MalfunctionDec 16, 2021Melted; Melted

  N/A.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13018893 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K864380. One submission often covers many models, so check the product and lot details in each record.

• Z-0381-2012 · Oct 10, 2011 · Terminated
  UltraLite Headlight module-grey Model: 001328 Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light source for surgica
• Z-0377-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Headlight System sweatband Model: AXI385BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light sour
• Z-0375-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Headlight System Headband Model: AXI375BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity light sourc
• Z-0380-2012 · Oct 10, 2011 · Terminated
  Mark II Headlight module-black with short linkage Model: 001380LXSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensity li
• Z-0373-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Pro Headlight with 9ft bifurcated cable Model: AX2000BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensit
• Z-0374-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Headlight System with 9ft premium bifurcated cable Model: AX2100BIF Product Usage: The fiber optic headlight system Is designed to deliver illumination from a h
• Z-0376-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Headlight System with short linkage Model: AX 1375BIFSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high intensit
• Z-0378-2012 · Oct 10, 2011 · Terminated
  Luxtec UltraLite Headlight System sweatband with short linkage Model: AXI385BIFSL Product Usage: The fiber optic headlight system Is designed to deliver illumination from a high