One-Step™ 00884450092606Recalls & reported problems
Merit Medical Systems, Inc. · Class 1
All models of One-Step (11)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00884450092606), received between Jan 9, 2023 and Sep 8, 2026 — classified as 1 injury, 3 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (1 report).
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Air/Gas in Device1
- Fluid/Blood Leak1
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Pneumothorax1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 8, 2026Air/Gas in Device
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50677566 ↗MalfunctionMar 4, 2026Gas/Air Leak
THE ACCOUNT ALLEGES THAT DURING USE, THE CATHETER IS NOT FUNCTIONING APPROPRIATELY AND PULLS AIR INTO THE PATIENT. NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24507102 ↗InjuryFeb 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN EMPLOYEE CONDUCTED A PMCF REVIEW FOR A DRAINAGE CATHETER. THE DRAINAGE CATHETER WAS USED TO TREAT A MALE PATIENT WITH A PLEURAL EFFUSION. THE PRIMARY USAGE OF THE DEVICE WAS TO FACILITATE PERCUTANEOUS DRAINAGE OF FLUIDS. THE LITERATURE REVIEWED ALLEGES THAT DURING THE USE OF THE DRAINAGE CENTESIS CATHETER A PLEURAL EFFUSION THE PATIENT ACQUIRED A PNEUMOTHORAX. NO ADDITIONAL INFO WAS RECEIVED FOR THE LITERATURE REVIEW. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: Pneumothorax
MAUDE report 21471484 ↗MalfunctionJan 9, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT A DRAINAGE CATHETER IS LEAKING FLUID FROM THE VALVE DURING A THORACENTESIS. NO PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16127817 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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