Medex MX4705Recalls & reported problems
Icu Medical, Inc. · Class 1
All models of Medex (98)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This ICU Medical Medex MX4705 pressure infusor squeezes IV bags to help IV fluids flow in faster. The 36 reports mostly describe air or gas leaking from the pressure bag or inflation nozzle, sometimes with the nozzle coming loose, plus cracked or broken parts and pressure that would not build. No deaths and no injuries were reported. There are no recalls naming 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
- 36
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 10351688507037), received between Jan 4, 2022 and Dec 1, 2025 — classified as 36 malfunctions.
The most frequently reported specific device problem is “Gas/Air Leak” (20 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Gas/Air Leak20
- Leak/Splash8
- Crack4
- Detachment of Device or Device Component4
- Unintended Deflation3
- Decrease in Pressure2
- Fluid/Blood Leak2
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Insufficient Information10
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PRESSURE BAG WAS LEAKING, THE DEVICE WAS NEWLY PURCHASED AND STILL UNUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23680570 ↗MalfunctionNov 12, 2025Leak/Splash; Detachment of Device or Device Component; Gas/Air Leak; Leak/Splash; Detachment of Device or Device Component; Gas/Air Leak
IT WAS REPORTED THAT THE DEVICE EXHIBITED AIR LEAKAGE WITH THE INFLATION NOZZLE DETACHED. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536334 ↗MalfunctionNov 12, 2025Leak/Splash; Detachment of Device or Device Component; Gas/Air Leak; Leak/Splash; Detachment of Device or Device Component; Gas/Air Leak
IT WAS REPORTED THAT THE DEVICE EXHIBITED AIR LEAKAGE WITH THE INFLATION NOZZLE DETACHED. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536294 ↗MalfunctionNov 12, 2025Leak/Splash; Detachment of Device or Device Component; Gas/Air Leak; Leak/Splash; Detachment of Device or Device Component; Gas/Air Leak
IT WAS REPORTED THAT THE DEVICE EXHIBITED AIR LEAKAGE WITH THE INFLATION NOZZLE DETACHED. THERE WAS NO PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23536232 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PRESSURE INFUSOR EXHIBITED AIR LEAKAGE AND DEBONDING. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22770296 ↗MalfunctionAug 11, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT THE PRESSURE INFUSOR EXHIBITED AIR LEAKAGE AND DEBONDING. THERE WAS NO PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22770131 ↗MalfunctionFeb 12, 2025Fracture; Product Quality Problem; Fracture; Product Quality Problem
IT WAS REPORTED THAT THE CONNECTING PIPE WAS BROKEN. THE EVENT OCCURRED ON 12-JAN-2025. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21368251 ↗MalfunctionOct 7, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE NURSE FOUND THAT THE PRESSURIZED BAG BEGAN TO LEAK AND COULD NOT REACH 300MMHG FOR CLINICAL USE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20391376 ↗MalfunctionSep 27, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE CLINICIANS REPORTED THAT UPON CHECKING, THERE WAS LEAKAGE AND AIR LEAKAGE AT THE GAPS BETWEEN THE EDGES OF THE PRESS. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322474 ↗MalfunctionSep 27, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT UPON CHECKING, THERE WAS LEAKAGE AND AIR LEAKAGE AT THE GAPS BETWEEN THE EDGES OF THE PRESS. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322269 ↗MalfunctionSep 27, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT UPON CHECKING, THERE WAS LEAKAGE AND AIR LEAKAGE AT THE GAPS BETWEEN THE EDGES OF THE PRESS. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20322120 ↗MalfunctionJun 18, 2024Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THERE WAS LEAKAGE ON PRESSURE INFUSOR AND WAS RESOLVED BY REPLACING WITH A NEW PRODUCT. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19562936 ↗MalfunctionJun 10, 2024Decrease in Pressure; Gas/Air Leak; Decrease in Pressure; Gas/Air Leak
IT WAS REPORTED THAT THE THIRD DAY OF THE PATIENT'S CARDIAC SURGERY, THE NURSE FOUND THAT THE THREE-WAY CONNECTION OF THE PRESSURIZED BAG WAS LEAKING AND RESULTED IN INSUFFICIENT PRESSURE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19498423 ↗MalfunctionJun 7, 2024Crack; Gas/Air Leak; Crack; Gas/Air Leak
IT WAS REPORTED THAT THERE WAS AN AIR LEAK AND COULD NOT BE PRESSURIZED NORMALLY. THE AIR LEAK WAS ALLEGED TO BE IN ONE OF THE CRACKS UNDERNEATH. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19488655 ↗MalfunctionMay 30, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT THE DEVICE WAS DEFECTIVE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 19428708 ↗MalfunctionMay 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn
IT WAS REPORTED THAT THE SIDE OF THE PRESSURE BAG SPLIT. THE PRODUCT FAULT OCCURRED FOUND WHILE IN USE WITH PATIENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19359117 ↗MalfunctionMay 21, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THERE WAS LEAKAGE ON PRESSURE THE INFUSOR. THE PRODUCT FAULT OCCURRED FOUND WHILE IN USE WITH PATIENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19358854 ↗MalfunctionMay 1, 2024Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE HOSPITAL EXPERIENCED AN AIR LEAK DURING CLINICAL USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19220261 ↗MalfunctionDec 6, 2023Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THERE WAS LEAKAGE DURING USE. ADVERSE EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18280020 ↗MalfunctionDec 6, 2023Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THERE WAS LEAKAGE DURING USE. ADVERSE EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18280019 ↗MalfunctionDec 6, 2023Disconnection; Disconnection
IT WAS REPORTED THAT DURING USE, "THE BLUE BALLOON CONNECTING TUBE WAS DISCONNECTED DURING USE". ADVERSE EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18280018 ↗MalfunctionDec 6, 2023Crack; Gas/Air Leak; Crack; Gas/Air Leak
IT WAS REPORTED THAT THE BOTTOM OF THE PRESSURIZED BAG CRACKED AND LEAKED DURING USE. ADVERSE EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18280017 ↗MalfunctionDec 6, 2023Crack; Gas/Air Leak; Crack; Gas/Air Leak
IT WAS REPORTED THAT THE BOTTOM OF THE PRESSURIZED BAG CRACKED AND LEAKED DURING USE. ADVERSE EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 18280016 ↗MalfunctionDec 6, 2023Crack; Gas/Air Leak; Crack; Gas/Air Leak
IT WAS REPORTED THAT THE BOTTOM OF THE PRESSURIZED BAG CRACKED AND LEAKED DURING USE. ADVERSE EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18280015 ↗MalfunctionJul 11, 2023Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT THE BAG WAS LEAKING, NOT KEEPING FULL. ADVERSE PATIENT EFFECTS ARE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 17302311 ↗
Other INFUSOR, PRESSURE, FOR I.V. BAGS devices
- InfuseIT ZIT-520Salter Labs · INFUSOR, PRESSURE, FOR I.V. BAGS19 reports
- Medex MX4810Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS15 reports
- Medline DYNJAAPI1000SMedline Industries, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS1 death9 reports
- Medex MX4805Icu Medical, Inc. · INFUSOR, PRESSURE, FOR I.V. BAGS9 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
- Vital Signs IN800048Hygia Health Services, Inc. · 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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