DTX(TM) PLUS DT-DL60 682028Recalls & reported problems
Argon Critical Care Systems Singapore Pte. Ltd. · a 3-way 20 drops adset with 60" tube length on each channel. 1 chnnel is connected with a 3cc transducer which is connected with a 48" pressure tubing and a 12" tubing. The sideport of the transducer is connected to a critiflo. Other end of the critiflo is connected to the 2nd channel of the Adset . The Critiflo also connected with a 48" and a 12" pressure tubings. The 3rd channel is left open. There is a separately packed 3xmale & a female protective caps. · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00886333620289), received between Feb 26, 2020 and Feb 26, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Puncture/Hole” (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 16, 2026.
Most reported problems
Device problems
- Material Puncture/Hole1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 26, 2020Material Puncture/Hole; Material Puncture/Hole
THE ACCOUNT ALLEGES THAT A HOLE WAS FOUND IN THE TUBING OF THE DEVICE BEFORE USE ON A PATIENT. NO ADVERSE CONSEQUENCES WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9759474 ↗
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
- DTX(TM) PLUS DT-4812 682000Argon Critical Care Systems Singapore Pte. Ltd. · System, Measurement, Blood-Pressure, Non-Invasive86 reports
- Medline MDS7001BMedline Industries, Inc. · System, measurement, blood-pressure, non-invasive81 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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