DTX(TM) PLUS DT-4812 682000Recalls & reported problems
Argon Critical Care Systems Singapore Pte. Ltd. · Pressure Monitoring Kits with 1-way 60 drops, 60" tube Adset connected with a 3cc transducer and a 48" & 12" Pressure Tubings · Class 2
Quick summary
This Argon DTX Plus blood pressure monitoring kit is used to measure pressure during procedures. The 86 reports mostly describe fluid leaking from the transducer or stopcocks, with one report mentioning blood loss in a child; there are no deaths and 1 injury. No recalls name this device, and no reports were filed in either of the last two 12-month periods.
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
- 86
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 00886333620005), received between Jul 9, 2020 and Dec 20, 2023 — classified as 1 injury, 85 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (84 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak84
- Crack1
- Decrease in Pressure1
- Loose or Intermittent Connection1
Patient problems
- No Clinical Signs, Symptoms or Conditions75
- No Consequences Or Impact To Patient6
- No Known Impact Or Consequence To Patient4
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 25 most recent of 86 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 20, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES AFTER BLOOD COLLECTION, BLOOD LEAKED FROM THE SPLIT SEPTUM OF THE 4-WAY STOP COCK WHEN RETURNING DILUTED BLOOD TO THE PATIENT. THE DEVICE WAS REPLACED. NO ADDITIONAL PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18365918 ↗InjuryJul 25, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES DURING USE ON A PEDIATRIC PATIENT, THE COLLECTION POINT BEGAN TO LEAK AND PATIENT LOST A LOT OF BLOOD. THE DEVICE WAS SWITCHED OUT FOR ANOTHER ONE.
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 17393782 ↗MalfunctionJun 6, 2023Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING A HEMODYNAMIC PRESSURE MONITORING PROCEDURE, THE CLINICAL STAFF NOTED THAT THE PRESSURE MONITORING SET WAS LEAKING FLUID WHILE CONNECTED TO THE PATIENT. THE DEVICE WAS REPLACED FOR THE PATIENT. NO ADDITIONAL PATIENT CONSEQUENCES TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17076331 ↗MalfunctionAug 23, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING PREPARATION, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE "PIPE" OF THE TRANSDUCER. NO PATIENT CONSEQUENCE TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15279927 ↗MalfunctionAug 17, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE TRANSDUCER. THE PM SET WAS DISCARDED. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15241850 ↗MalfunctionAug 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE 3-WAY STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15195718 ↗MalfunctionAug 9, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE TRANSDUCER. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15195706 ↗MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE 3-WAY STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15008260 ↗MalfunctionJul 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE 3-WAY STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15008252 ↗MalfunctionJun 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE 3-WAY STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14861645 ↗MalfunctionJun 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE 3-WAY STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14861318 ↗MalfunctionJun 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE 3-WAY STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14861233 ↗MalfunctionJun 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE 3-WAY STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14861090 ↗MalfunctionJun 29, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE 3-WAY STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14860985 ↗MalfunctionMay 19, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, BLOOD WAS OBSERVED TO BE GOING BACKWARD. THE SET WAS FOUND TO BE LEAKING BETWEEN THE BLOOD SAMPLE PORT AND THE TUBING. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14439185 ↗MalfunctionMay 19, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM A CONNECTION NEAR THE P SEPTUM. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14439122 ↗MalfunctionMay 19, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM A CONNECTION NEAR THE P SEPTUM. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14439028 ↗MalfunctionMay 19, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE 3-WAY STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14438871 ↗MalfunctionMay 19, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM A CONNECTION NEAR THE P SEPTUM. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14438857 ↗MalfunctionMay 19, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM A CONNECTION NEAR THE P SEPTUM. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14438849 ↗MalfunctionMay 19, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM A CONNECTION NEAR THE P SEPTUM. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14438793 ↗MalfunctionMay 19, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM A CONNECTION NEAR THE P SEPTUM. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14438627 ↗MalfunctionMay 4, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14279323 ↗MalfunctionApr 13, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGEST THAT DURING USE SALINE HAD LEAKED OUT OF A CRACK IN THE STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14107000 ↗MalfunctionApr 5, 2022Fluid/Blood Leak; Fluid/Blood Leak
THE ACCOUNT ALLEGES THAT DURING THE HEMODYNAMIC MONITORING OF A PATIENT, THE PRESSURE MONITORING [PM] SET WAS FOUND TO BE LEAKING FLUID FROM THE STOPCOCK. NO PATIENT INJURY TO REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14016021 ↗
Other System, Measurement, Blood-Pressure, Non-Invasive devices
- Medline MDS5001Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive747 reports
- Medline MDS4003Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive398 reports
- Medline MDS4001Medline Industries, Inc. · System, measurement, blood-pressure, non-invasive267 reports
- Medline MDS3001UMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive170 reports
- Medline MDS1001CSMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive1 recall57 reports
- Ultraview SL Ultraview SL®Spacelabs Healthcare (Washington), Inc · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE2 recalls2 reports
- Medline MDS7001BMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive81 reports
- Acumen IQ Cuff Adult AIQCAEdwards Lifesciences LLC · System, Measurement, Blood-Pressure, Non-Invasive64 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.