Medex MX9604ARecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10351688502933), received between Apr 12, 2017 and Jul 14, 2026 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 reports).

1 other recall cover devices cleared under the same FDA submission (K820355); they may or may not involve this specific model.

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.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2026Leak/Splash; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25813230 ↗
• MalfunctionAug 22, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CONNECTOR WAS BROKEN, CAUSING BLOOD LEAKAGE. THE REPORTED EVENT OCCURRED DURING A TREATMENT AT THE OPERATION ROOM. THE EVENT OCCURRED DURING PATIENT USE, HOWEVER, NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22872468 ↗
• MalfunctionAug 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHEN INSTALLING THE INVASIVE BLOOD PRESSURE TRANSDUCER, SALINE SOLUTION LEAKAGE OCCURRED IN THE VALVE OF THE WASHING SYSTEM. THE EVENT OCCURRED IN THE ADULT ICU, AND THE PROCEDURE THAT WAS BEING PERFORMED AT THE TIME WAS CATHETERIZATION/ANGIOPLASTY. THE CUSTOMER INFORMED THAT THE EVENT WAS OBSERVED IN PRE-TEST, BEFORE USE, BUT THE TRANSDUCER WAS ALREADY INSTALLED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19906917 ↗
• MalfunctionJan 31, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THERE WAS A LEAK IN THE CIRCUIT WASHING CONNECTION. THE EVENT OCCURRED AT "SUBCC" AREA, DURING USE, HOWEVER, NO INJURIES, HARM OR ADVERSE EVENTS OCCURRED. THE PROCEDURE INVOLVED SUTURING EXTENSIVE INJURIES, NO OTHER DEFECTS WERE DETECTED IN THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18617880 ↗
• MalfunctionSep 1, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE MATERIAL TIP SHOWED BREAKAGE WHEN CONNECTING TO THE VIAL. THE EVENT OCCURRED IN THE INTENSIVE CARE UNIT. THE CUSTOMER REPORTED THAT NO HARM CAME TO THE PATIENT DUE TO THIS ISSUE. THE PATIENT HAD FLU SYDROME, ACUTE CRI AND HYPERKALEMIA. THE PATIENT WAS TREATED WITH MEDICATION AND THE ISSUE WAS RESOLVED. DUE TO THE REPORTED ISSUE, THE PATIENT WAS EXPOSED TO REPEATED PROCEDURE AND A THERAPEUTIC DELAY. THE SAMPLE IS NOT AVAILABLE FOR INVESTIGATION, HOWEVER A PICTURE WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17669542 ↗
• MalfunctionSep 9, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE PLASTIC PART OF THE DOME, WHERE THE TRANSDUCER IS ATTACHED TO THE EQUIPMENT, IS STUCK IN THE STRUCTURE MAKING IT IMPOSSIBLE TO CONNECT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15396806 ↗
• MalfunctionSep 9, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE SENSOR DOES NOT DETECT THE MODULE THAT IS CONNECTED TO THE MULTI-PARAMETER MONITOR, SO PRESSURE TRANSDUCER CANNOT BE USED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15392373 ↗
• MalfunctionSep 7, 2022Display Difficult to Read; Incorrect, Inadequate or Imprecise Result or Readings; Display Difficult to Read; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PRODUCT HAD A DEFECT IN THE NOTIFICATION OF CONTINUOUS BLOOD PRESSURE, AND IT IS NOT POSSIBLE TO MAKE A RELIABLE READING. THE ITEM WAS REPLACED AND ISSUE WAS RESOLVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370684 ↗
• MalfunctionSep 7, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE DEVICE PRESENTED AN ERROR IN THE READING, REQUIRING THE USE OF ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15370070 ↗
• MalfunctionJul 21, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT SERUM WAS LEAKING AFTER FILLING A MEDEX¿ LOGICAL® PRESSURE MONITORING SET. THERE WAS NO PATIENT INVOLVEMENT; THE PROBLEM WAS IDENTIFIED AFTER ASSEMBLY.

  Patient problems: No Patient Involvement

  MAUDE report 6732343 ↗
• MalfunctionJul 14, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE OF THE SOLUTION OCCURRED IN A MEDEX LOGICAL PRESSURE MONITORING SYSTEM. IT WAS NOTED THAT MISASSEMBLE AND IMPROPER USE WAS RULED OUT AS A PROBABLE CAUSE. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6714695 ↗
• MalfunctionJul 14, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE OF THE SOLUTION OCCURRED IN A MEDEX LOGICAL PRESSURE MONITORING SYSTEM. IT WAS NOTED THAT MISASSEMBLE AND IMPROPER USE WAS RULED OUT AS A PROBABLE CAUSE. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6714686 ↗
• MalfunctionJul 14, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT LEAKAGE OF THE SOLUTION OCCURRED IN A MEDEX LOGICAL PRESSURE MONITORING SYSTEM. IT WAS NOTED THAT MISASSEMBLE AND IMPROPER USE WAS RULED OUT AS A PROBABLE CAUSE. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6714677 ↗
• MalfunctionJul 12, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A LEAK WAS DETECTED THROUGH THE TRANSDUCER "TAP" OF A MEDEX LOGICAL PRESSURE MONITORING SYSTEM. IT WAS NOTED THAT THE TRANSDUCER WAS IN USE "WITH HYPERTENSION MARKING" DURING CARDIAC SURGERY, "WITHOUT COMMITTING TO THE PATIENT'S CLINIC". IT WAS ALSO NOTED THAT "THE ARTERIAL PUNCTURE WAS DETECTED" WHEN THE LEAKAGE WAS DETECTED. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6708551 ↗
• MalfunctionJul 10, 2017Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING SETUP OF A MEDEX LOGICAL SINGLE MONITORING KIT, SERUM LEAKAGE OCCURRED IN THE VALVE. IT WAS NOTED THAT THE DEVICE WAS BEING SET UP TO CARRY OUT A PROCEDURE. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6697492 ↗
• MalfunctionApr 12, 2017Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A MEDEX LOGICAL PRESSURE MONITORING SYSTEM HAD LEAKAGE AT THE CONNECTION DURING USE. THE NURSE ATTEMPTED TO ADJUST THE CONNECTION BUT THE LEAKAGE REMAINED. THE DEVICE WAS REPLACED TO ADDRESS THE ISSUE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6487525 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K820355. One submission often covers many models, so check the product and lot details in each record.

• Z-0739-2024 · Nov 10, 2023 · Open, Classified
  Medex LOGICAL CATH LAB KIT, List Number M20754