Flex-X 11278A1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04048551226339), received between Feb 7, 2025 and Sep 22, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (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

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Display or Visual Feedback Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860222 ↗
• MalfunctionApr 3, 2026Display or Visual Feedback Problem

  IT WAS REPORTED THAT OPTICAL SYSTEM DAMAGED FOR NO APPARENT REASON, CAUSING BLURRED VISION. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24779629 ↗
• MalfunctionMar 13, 2026Crack

  IT WAS REPORTED: "THE DEFLECTION IS DEFECTIVE". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24591615 ↗
• MalfunctionDec 24, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING URETEROSCOPY, THE ANGLED GUIDEWIRE APPEARED TO BREAK WHILE BEING MANIPULATED OVER THE GUIDEWIRE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23890606 ↗
• MalfunctionDec 22, 2025Erratic or Intermittent Display; Fracture; Erratic or Intermittent Display; Fracture

  ACCORDING TO THE INFORMATION RECEIVED, IMAGE DROPOUTS DURING PROCEDURE OBSERVED AND A LEAKAGE. NO DEATH OR (UNANTICIPATED) SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865585 ↗
• MalfunctionFeb 7, 2025Optical Obstruction; Physical Resistance/Sticking; Optical Obstruction; Physical Resistance/Sticking

  IT WAS REPORTED THAT: THERE'S AIR LEAKAGE HAPPENING, AND THE WORKING CHANNEL IS CLOGGED. THE DEFLECTION IS EITHER INSUFFICIENT. NO INFORMATION ABOUT PATIENT INJURY AND NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 21334637 ↗