Midline Catheter Kit P4154118Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00801741140990), received between Dec 3, 2025 and Sep 2, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50572814 ↗
• MalfunctionDec 3, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  IT WAS REPORTED INTRODUCER WAS VERY DIFFICULT TO SEPARATE/REMOVE. NO ADVERSE EVENT OR INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708516 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BLOOD RETURN SLUGGISH REQUIRED FLUSHING AND REPOSITIONING. MIDLINE FAILED 48HRS POST INSERTION PATIENT HAD EXTREME PAIN. PATIENT HAD TO COME TO ER GET IV STARTED WAS VERY UPSET. NO ADVERSE EVENT OR INJURY WAS REPORTED.

  Patient problems: Pain

  MAUDE report 23708358 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BLOOD RETURN ADEQUATE BUT DIFFICULT TO ILLICIT AFTER CONNECTOR APPLIED HAD TO FLUSH OFTEN AND THEN PULL BACK 1CM TO OBTAIN ADEQUATE BLOOD RETURN AGAIN NOTED SMALL BUBBLES WHEN DRAWING BACK. NO ADVERSE EVENT OR INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708355 ↗
• MalfunctionDec 3, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED BLOOD RETURN WAS INTERMITTENT POST INSERTION AFTER CONNECTOR APPLIED TRIED REPOSITIONING/PULLING BACK MULTIPLE FLUSHES BEFORE JUST FAIR BLOOD RETURN ESTABLISHED NOTED SMALL BUBBLES WHEN DRAWING BACK. REQUIRED ANOTHER INSERTION IN OTHER ARM AS WAS SCHEDULED FOR MAID. NO ADVERSE EVENT OR INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23708346 ↗