Smiths Medical MX4705Recalls & reported problems
Hygia Health Services, Inc. · Clear Cuff® 500ml pressure infusor · Class 1
Data updated Oct 18, 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 10817357020622), received between Apr 2, 2025 and Apr 2, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Gas/Air Leak” (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
- Gas/Air Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 2, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT WHILE CENTRAL VENOUS PRESSURE MONITORING WAS PERFORMED ON THE PATIENT, A LEAK OF AIR WAS FOUND IN THE PRODUCT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21756277 ↗
Other Infusor, Pressure, For I.V. Bags devices
- Medex MX4705Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS36 reports
- InfuseIT ZIT-520Salter Labs · INFUSOR, PRESSURE, FOR I.V. BAGS19 reports
- Medex MX4810Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS15 reports
- Medex MX4805Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS9 reports
- Medline DYNJAAPI1000SMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS1 death9 reports
- Medline DYNJPI500CMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS7 reports
- Medline DYNJAAPI500SMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS6 reports
- Vital Signs™ IN800012Airlife · INFUSOR, PRESSURE, FOR I.V. BAGS3 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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