Merit Medical® 00884450345443Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450345443), received between Jul 8, 2025 and Jul 8, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Jun 11, 2024Class IIOpen, Classified

   Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

   Z-2579-2024 · Root cause: No Marketing Application · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 8, 2025Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THE ONE STEP CATHETER WAS PLACED IN THE PATIENT AND A 50 ML LUER LOCK SYRINGE WAS ATTACHED TO OBTAIN FLUID FOR LABS. THE FLUID WAS DRAWN INTO THE SYRINGE. THE HUB THEN BROKE OFF INTO THE LUER LOCK WHEN TWISTING THE SYRINGE TO REMOVE IT FROM THE ONE STEP CATHETER. THIS PREVENTED THE IV LINE FROM BEING ATTACHED TO THE CATHETER. THE CLINICIAN REMOVED THE CATHETER AND INSERTED ANOTHER TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437669 ↗
• MalfunctionJul 8, 2025Fracture; Material Fragmentation; Material Separation; Fracture; Material Fragmentation; Material Separation

  THE ACCOUNT ALLEGES THE ONE STEP CATHETER WAS PLACED IN THE PATIENT AND A 50 ML LUER LOCK SYRINGE WAS ATTACHED TO OBTAIN FLUID FOR LABS. THE FLUID WAS DRAWN INTO THE SYRINGE. THE HUB THEN BROKE OFF INTO THE LUER LOCK WHEN TWISTING THE SYRINGE TO REMOVE IT FROM THE ONE STEP CATHETER. THIS PREVENTED THE IV LINE FROM BEING ATTACHED TO THE CATHETER. THE CLINICIAN REMOVED THE CATHETER AND INSERTED ANOTHER TO COMPLETE THE PROCEDURE. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437646 ↗