One-Step™ 00884450092644Recalls & 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
Quick summary
This Merit Medical One-Step irrigation catheter is used to flush or drain fluid during procedures. Most of the 30 reports describe fluid or blood leaking from the catheter, particularly from its valve after it was placed; a few mention the catheter breaking or failing to collect a biopsy sample. Four reports describe injuries, and there were no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 00884450092644), received between Jun 29, 2022 and Oct 11, 2022 — classified as 4 injuries, 25 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (29 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 Leak29
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- Pneumothorax1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
InjuryOct 11, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15583937 ↗InjuryOct 11, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15583602 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510351 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510347 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510157 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510151 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510137 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510134 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510070 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510066 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510055 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510053 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510033 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510029 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510023 ↗MalfunctionSep 30, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE AFTER ACQUIRING PATIENT ACCESS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15510019 ↗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 15335751 ↗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 15335747 ↗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 15335744 ↗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 15335736 ↗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 15335733 ↗MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE PARACENTESIS PROCEDURE, THE VALVE DID NOT CLOSE UPON REMOVAL OF THE METAL STYLET RESULTING IN FLUID GETTING ON THE CLINICAN. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15008572 ↗MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE PARACENTESIS PROCEDURE, THE VALVE DID NOT CLOSE UPON REMOVAL OF THE METAL STYLET RESULTING IN FLUID GETTING ON THE CLINICAN. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15008570 ↗MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE PARACENTESIS PROCEDURE, THE VALVE DID NOT CLOSE UPON REMOVAL OF THE METAL STYLET RESULTING IN FLUID GETTING ON THE CLINICAN. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15008564 ↗MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE PARACENTESIS PROCEDURE, THE VALVE DID NOT CLOSE UPON REMOVAL OF THE METAL STYLET RESULTING IN FLUID GETTING ON THE CLINICAN. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15008533 ↗
Other CATHETER, IRRIGATION devices
- Navarre Opti-Drain NOD8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION901 reports
- Navarre NNU8LPTBard Access Systems, Inc. · CATHETER, IRRIGATION736 reports
- BLAKE 2227Ethicon Inc. · CATHETER, IRRIGATION331 reports
- Navarre NNU6LPTBard Access Systems, Inc. · CATHETER, IRRIGATION211 reports
- Navarre Opti-Drain NOD10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION178 reports
- Navarre NNU10LPTBard Access Systems, Inc. · CATHETER, IRRIGATION127 reports
- BLAKE 2233Ethicon Inc. · CATHETER, IRRIGATION114 reports
- Vasoshield VH-5001Maquet Cardiovascular LLC · Catheter, Irrigation1 recall27 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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