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One-Step™ 00884450092538Recalls & reported problems

Merit Medical Systems, Inc. · Class 1

All models of One-Step (11)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450092538), received between Sep 1, 2022 and Sep 1, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Device problems

  • Fluid/Blood Leak2

Patient problems

  • No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

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

  • MalfunctionSep 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

    THE ACCOUNT ALLEGES DURING A DRAINAGE PROCEDURE, THE DRAINAGE CATHETER VALVES WERE LEAKING FLUID AS THE NEEDLE WAS BEING REMOVED. NO PATIENT INJURY TO REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15335787 ↗
  • MalfunctionSep 1, 2022Fluid/Blood Leak; Fluid/Blood Leak

    THE ACCOUNT ALLEGES DURIING A DRAINAGE PROCEDURE, THE DRAINAGE CATHETER VALVES WERE LEAKING FLUID AS THE NEEDLE WAS BEING REMOVED. NO PATIENT INJURY TO REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15335755 ↗

Other CATHETER, IRRIGATION devices

All CATHETER, IRRIGATION devices →

Sources and updates

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