One-Step™ 00884450092712Recalls & reported problems
Merit Medical Systems, Inc. · Class 1
Quick summary
This Merit Medical One-Step irrigation catheter is used to flush fluid during procedures. The 30 reports all describe the same thing: fluid or blood leaking from the device while it was in use. None of the reports describe any harm to the patient, and there were no deaths or injuries. 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
- 30
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00884450092712), received between Oct 20, 2022 and Oct 20, 2022 — classified as 30 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (30 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
Device problems
- Fluid/Blood Leak30
Patient problems
- No Clinical Signs, Symptoms or Conditions30
Recent adverse event reports
The 25 most recent of 30 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642724 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642716 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642710 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642704 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642374 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642361 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642356 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642353 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642348 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642345 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642342 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642341 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642337 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642333 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642331 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642329 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642328 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642324 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642323 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642322 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642320 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642315 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642313 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642312 ↗MalfunctionOct 20, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE DEVICE WAS FOUND TO BE LEAKING. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15642306 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.