N/A (REF 401223)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885825005818), received between Dec 16, 2024 and Dec 16, 2024 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (6 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.

• MalfunctionDec 16, 2024Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation; Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT THE CUSTOMER WAS FACING A FEW ISSUES WITH THE CATHETER. AS REPORTED, THE CATHETER BARELY COME OUT OF THE TRANSPARENT SLEEVE, THE SHAPE IS NOT AS NORMAL, THEY ARE MORE "WRINKLED" THAN USUAL AND DON¿T KEEP THEIR BASIC SHAPE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20940700 ↗
• MalfunctionDec 16, 2024Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation; Device Handling Problem; Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation; Device Handling Problem

  IT WAS REPORTED THAT THE CUSTOMER WAS FACING A FEW ISSUES WITH THE CATHETER. AS REPORTED, THE CATHETER BARELY COME OUT OF THE TRANSPARENT SLEEVE, THE SHAPE IS NOT AS NORMAL, THEY ARE MORE "WRINKLED" THAN USUAL AND DON¿T KEEP THEIR BASIC SHAPE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20940698 ↗
• MalfunctionDec 16, 2024Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation; Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT THE CUSTOMER WAS FACING A FEW ISSUES WITH THE CATHETER. AS REPORTED, THE CATHETER BARELY COME OUT OF THE TRANSPARENT SLEEVE, THE SHAPE IS NOT AS NORMAL, THEY ARE MORE "WRINKLED" THAN USUAL AND DON¿T KEEP THEIR BASIC SHAPE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20940695 ↗
• MalfunctionDec 16, 2024Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation; Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT THE CUSTOMER WAS FACING A FEW ISSUES WITH THE CATHETER. AS REPORTED, THE CATHETER BARELY COME OUT OF THE TRANSPARENT SLEEVE, THE SHAPE IS NOT AS NORMAL, THEY ARE MORE "WRINKLED" THAN USUAL AND DON¿T KEEP THEIR BASIC SHAPE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20940221 ↗
• MalfunctionDec 16, 2024Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation; Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT THE CUSTOMER WAS FACING A FEW ISSUES WITH THE CATHETER. AS REPORTED, THE CATHETER BARELY COME OUT OF THE TRANSPARENT SLEEVE, THE SHAPE IS NOT AS NORMAL, THEY ARE MORE "WRINKLED" THAN USUAL AND DON'T KEEP THEIR BASIC SHAPE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20940207 ↗
• MalfunctionDec 16, 2024Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation; Use of Device Problem; Difficult to Open or Remove Packaging Material; Material Deformation

  IT WAS REPORTED THAT THE CUSTOMER WAS FACING A FEW ISSUES WITH THE CATHETER. AS REPORTED, THE CATHETER BARELY COME OUT OF THE TRANSPARENT SLEEVE, THE SHAPE IS NOT AS NORMAL, THEY ARE MORE "WRINKLED" THAN USUAL AND DON¿T KEEP THEIR BASIC SHAPE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION AND EXTENDED PROCEDURE TIME REPORTED WAS A FEW MINUTES. THESE ARE COMMONLY USED DEVICES THAT ARE READILY AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20940194 ↗