Medex MX390Recalls & reported problems
Icu Medical, Inc. · Class 2
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10351688507884), received between Sep 25, 2019 and Apr 29, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Pressure Problem” (3 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.
Most reported problems
Device problems
- Pressure Problem3
- Defective Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 29, 2023Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THE PRESSURE INDICATION IS WRONG. THE REAL PRESSURE OF THE PRESSURE PUMP CANNOT BE PREDICTED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16841277 ↗MalfunctionDec 17, 2021Defective Device; Defective Device
IT WAS REPORTED THAT DURING USE, THE REACTION OF THE PRESSURE GAUGE LAGGED BEHIND AND THE PRESSURE VALUE WAS INACCURATE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13030261 ↗MalfunctionSep 25, 2019Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THE POINTER ON THE PRESSURE GAUGE FAILED TO RETURN TO A VALUE OF ZERO DUE TO AN UNSPECIFIED REASON. IT WAS ALSO REPORTED THAT AT TIMES THE POINTER REGISTERED A HIGH VALUE AND SUDDENLY DROPPED. THE OPERATOR REPLACED THE DEVICE AFTER ENCOUNTERING THE AFOREMENTIONED PRODUCT PROBLEMS. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9119722 ↗MalfunctionSep 25, 2019Pressure Problem; Pressure Problem
IT WAS REPORTED THAT THE POINTER ON THE PRESSURE GAUGE FAILED TO RETURN TO A VALUE OF ZERO DUE TO AN UNSPECIFIED REASON. IT WAS ALSO REPORTED THAT AT TIMES THE POINTER REGISTERED A HIGH VALUE AND SUDDENLY DROPPED. THE OPERATOR REPLACED THE DEVICE AFTER ENCOUNTERING THE AFOREMENTIONED PRODUCT PROBLEMS. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9119720 ↗
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- Indeflator 1000185Abbott Vascular Inc. · Syringe, balloon inflation1 recall131 reports
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- Encore™ 26 M001151050Boston Scientific Corporation · Syringe, balloon inflation1 recall54 reports
- PRESTO ID4030Bard Peripheral Vascular, Inc. · Syringe, balloon inflation1 death98 reports
- Encore™ 26 Advantage Kit H74904527011Boston Scientific Corporation · Syringe, balloon inflation1 recall28 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.