NA 8404DXCRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04048551441947), received between Jun 23, 2025 and Sep 24, 2026 — classified as 1 death, 13 malfunctions.

The most frequently reported specific device problem is “Device Reprocessing Problem” (5 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

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026No Display/Image

  It was reported that during an intubation attempt completed by CMAC blade was used for laryngoscopy. Upon entering patient's mouth with scope, field of vision on video camera was black. physician was unable to visualize infant's mouth or vocal cords or throat. CMAC pulled from service and intubation successful with direct laryngoscopy blade. No negative impact in state of health reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50884593 ↗
• DeathSep 22, 2026Output below Specifications

  The following was reported: Patient was born at 33+4 weeks gestation. Following admission to the neonatal unit for prematurity and observation, the infant developed increasing respiratory distress, oxygen requirement and respiratory acidosis. Despite non-invasive respiratory support, the patients oxygen requirement remained around 30% and chest x-ray was consistent with Surfactant Lung Disease Deficiency. The clinical team therefore decided to proceed with Less Invasive Surfactant Administration using Karl Storz video laryngoscope.Attempts by different doctors were made to visualize the airway using video laryngoscope but difficulties were encountered with airway visualization, including reports of a dark video screen.The procedure was subsequently completed using a conventional laryngoscope. Shortly after the procedure, patient experienced sudden clinical deterioration with a significant right-sided tension pneumothorax identified. Emergency needle thoracocentesis and subsequent chest drains were unable to improve Patients condition, and patient died.The concern is that poor visualization using the Karl Storz video laryngoscope hindered successful LISA administration, and potentia

  Patient problems: Pneumothorax

  MAUDE report 50861620 ↗
• MalfunctionAug 6, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50161878 ↗
• MalfunctionJul 16, 2026Output below Specifications

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25849923 ↗
• MalfunctionMay 20, 2026Energy Output Problem

  IT WAS REPORTED THERE WAS NO LIGHT OUTPUT. NO PROCEDURE OR PATIENT INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25230583 ↗
• MalfunctionApr 28, 2026Energy Output Problem

  IT WAS REPORTED THAT "NO LIGHT". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25023622 ↗
• MalfunctionMar 11, 2026Loss of or Failure to Bond; Poor Quality Image; Optical Problem

  IT WAS REPORTED THERE WAS NO LIGHT COMING OUT OF THE DISTAL TIP, VIDEO IMAGE DARK. NO PROCEDURE OR PATIENT INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24569026 ↗
• MalfunctionFeb 19, 2026Device Reprocessing Problem; No Display/Image

  IT WAS REPORTED THAT THE LIGHT IS FLICKERING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 24397468 ↗
• MalfunctionDec 2, 2025Device Reprocessing Problem; Poor Quality Image; Optical Problem; Device Reprocessing Problem; Poor Quality Image; Optical Problem

  IT WAS REPORTED THERE IS NO IMAGE ON THE MONITOR, BLACK SCREEN NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23694534 ↗
• MalfunctionNov 19, 2025Device Reprocessing Problem; Output Problem; Device Reprocessing Problem; Output Problem

  IT WAS REPORTED THAT THE LIGHT IS WITHOUT FUNCTION / NO LIGHT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23598260 ↗
• MalfunctionNov 19, 2025Device Reprocessing Problem; Output Problem; Device Reprocessing Problem; Output Problem

  IT WAS REPORTED THAT THE LIGHT IS FLICKERING. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 23598258 ↗
• MalfunctionAug 20, 2025Device Reprocessing Problem; Poor Quality Image; Optical Problem; Device Reprocessing Problem; Poor Quality Image; Optical Problem

  IT WAS REPORTED THERE WAS NO LIGHT, VERY HARD TO SEE THROUGH. NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 22849109 ↗
• MalfunctionJun 23, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS FAILURE OF LED LIGHT, THE LED LIGHT "STARTING TO DIM AND THEN EVENTUALLY GONE OUT COMPLETELY". NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310762 ↗
• MalfunctionJun 23, 2025Output Problem; Output Problem

  IT WAS REPORTED THAT THERE WAS FAILURE OF LED LIGHT, THE LED LIGHT "STARTING TO DIM AND THEN EVENTUALLY GONE OUT COMPLETELY". NO PATIENT OR PROCEDURE INVOLVEMENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22310548 ↗