UltraLite® AX1375BIFRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10381780168836), received between Feb 7, 2019 and Feb 7, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Melted” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2019Melted; Overheating of Device; Melted; Overheating of Device

  INITIALLY MFG REPORT 2523190-2019-00013 WAS FILED WITH THE PRODUCT ID AX1375BIF ANCILLARY. HOWEVER, THE PRODUCT THAT WAS RECEIVED AND EVALUATED IS THE AX2100BIF ULTRALITE PRO HEADLIGHT W/PREMIUM CABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8318925 ↗

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-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
• 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-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-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-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-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-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