Medex MX1390Recalls & reported problems
Icu Medical, Inc. · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- 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 10351688510020), received between Mar 13, 2018 and Aug 1, 2018 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Crack” (2 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
- Crack2
- Leak/Splash2
- Pressure Problem2
- Decrease in Pressure1
- Fluid/Blood Leak1
Patient problems
- No Consequences Or Impact To Patient3
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 1, 2018Crack; Leak/Splash; Decrease in Pressure; Pressure Problem; Crack; Leak/Splash; Decrease in Pressure; Pressure Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING CORONARY ANGIOPLASTY A SMITHS MEDICAL MEDFLATOR®II INFLATION SYRINGE SYSTEM WOULD NOT HOLD PRESSURE DURING RELEASE OF THE STENT. AFTER FURTHER ATTEMPTS, THE INFLATION SYSTEM WOULD CONTINUE TO NOT KEEP PRESSURE. THE PRODUCT WAS THEN REPLACED WITH NO REPORTED ADVERSE EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7740926 ↗MalfunctionJul 12, 2018Crack; Pressure Problem; Crack; Pressure Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING A CARDIAC CATHETERIZATION PROCEDURE, THIS INFLATION SYRINGE SYSTEM DID NOT DEVELOP PRESSURE. THE PRODUCT WAS IMMEDIATELY REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7682381 ↗MalfunctionMar 14, 2018Leak/Splash; Leak/Splash
IT WAS REPORTED THAT A MEDEX¿ MEDFLATOR®II INFLATION SYRINGE SYSTEM WAS LEAKING DURING AN ANGIOPLASTY PROCEDURE. THE PRODUCT WAS REPLACED. NO INJURY WAS REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7338397 ↗MalfunctionMar 13, 2018Fluid/Blood Leak; Fluid/Blood Leak
INFORMATION WAS RECEIVED INDICATING THAT THIS SYRINGE INFLATION SYSTEM EXHIBITED LEAKAGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7335085 ↗
Other Syringe, balloon inflation devices
- Indeflator 1000184Abbott Vascular Inc. · Syringe, balloon inflation2 recalls155 reports
- Indeflator 1000186-115Abbott Vascular Inc. · Syringe, balloon inflation2 recalls124 reports
- Alliance II M00550600Boston Scientific Corporation · Syringe, balloon inflation191 reports
- Indeflator 1000185Abbott Vascular Inc. · Syringe, balloon inflation1 recall131 reports
- Indeflator 1000186Abbott Vascular Inc. · Syringe, balloon inflation2 recalls56 reports
- 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 and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page