Medex MX1390Recalls & reported problems

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

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 ↗