Medex MX9505TRecalls & reported problems

Summary

The FDA's MAUDE database contains 273 adverse event reports that list this exact device (DI 10351688503992), received between Sep 16, 2020 and Sep 21, 2026 — classified as 2 injuries, 271 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (56 reports).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K942377); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Sep 24, 2024Open, Classified

   Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device due to either a leak within the TranStar Disposable Pressure Transducer or from a defect within the TranStar Disposable Pressure Transducer chip.

   Z-0192-2025 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 273 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Fluid/Blood Leak; Reflux within Device

  It was reported that blood refluxed into the tubing after connecting the transducer to the radial artery catheter. After replacing the transducer, blood return and leakage stopped. There was a patient involvement and there were no additional adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50845233 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak; Reflux within Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50829696 ↗
• MalfunctionSep 18, 2026Fluid/Blood Leak

  It was reported that blood was drawn via the right radial artery catheter. During flushing, leakage was observed at the sealed connection between the saline line and sensor. The consumable was replaced. There was a patient involvement and there were no additional adverse consequences.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50818553 ↗
• MalfunctionSep 1, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50550658 ↗
• MalfunctionAug 31, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50519688 ↗
• MalfunctionJul 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074927 ↗
• MalfunctionJul 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074926 ↗
• MalfunctionJul 29, 2026Break; Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074903 ↗
• MalfunctionJul 29, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50074898 ↗
• MalfunctionMar 6, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE TRANSDUCER WAS DISPLAYING INTRACRANIAL PRESSURE (ICP) READINGS OF 25-45MMGH. THE PATIENT RECEIVED TREATMENT FOR THE INCREASED ICP READINGS INCLUDING MEDICATIONS AND A HEAD COMPUTED TOMOGRAPHY (CT). THE ELEVATED READINGS WERE NOT CORRELATING WITH THE CLINICAL PRESENTATION OF THE PATIENT. IT WAS UNSURE IF AN ACTUAL HARM WAS DONE TO THE PATIENT. IT WAS ALSO NOTED AFTER THE QUESTIONABLE TRANSDUCER WAS CHANGED OUT THAT THE WIRING HARNESS WHICH RUNS FROM THE PLUG TO THE TRANSDUCER WAS TWISTED. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24535294 ↗
• MalfunctionMar 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE PRODUCT HAD EXPERIENCED BLOOD BACKFLOW. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24512702 ↗
• MalfunctionMar 4, 2026Incorrect, Inadequate or Imprecise Result or Readings; Failure to Sense

  IT WAS REPORTED THAT AN 83-YEAR-OLD MALE PATIENT BORN ON 20-FEB-1942 HAD A RADIAL ARTERY CATHETER SUCCESSFULLY PLACED. AFTER CONNECTING THE TRANSDUCER, THE MONITOR DISPLAYED 'SENSOR DETACHED' AND DID NOT SHOW THE CONNECTED SENSOR. UPON CHECKING, THE ARTERIAL CATHETER PATHWAY WAS PATENT, THE PRESSURE TRANSDUCER AND PRESSURE CONNECTING LINE WERE SECURELY CONNECTED, AND THE PRESSURE TUBING AND PRESSURE MODULE WERE IN GOOD CONDITION. AFTER REPLACING THE TRANSDUCER, ALL DISPLAYS RETURNED TO NORMAL. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507917 ↗
• MalfunctionMar 4, 2026Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT AFTER USE, IT WAS FOUND THAT THE LIQUID INPUT VOLUME FAR EXCEEDED 3 ML/H, REACHING 10 ML/H. AFTER THE DOCTOR REPLACED THE PRESSURE SENSOR, IT RETURNED TO NORMAL. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24506162 ↗
• MalfunctionFeb 18, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE ANESTHESIOLOGY DEPARTMENT CONNECTED THE DEVICE FOR USE AND THE DOCTOR NOTICED BLOOD LEAKAGE AT THE JOINT. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24380510 ↗
• MalfunctionFeb 16, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE ANESTHESIOLOGY DEPARTMENT CONNECTED THE DEVICE FOR USE AND THE DOCTOR NOTICED BLOOD LEAKAGE AT THE JOINT. THERE WAS PATIENT INVOLVEMENT. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24345269 ↗
• MalfunctionFeb 3, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PRODUCT WAS LEAKING DURING USE. THERE WAS PATIENT INVOLVEMENT BUT NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246518 ↗
• MalfunctionJan 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS LEAKAGE AT THE CONNECTION BETWEEN THE PRODUCT'S FRONT END AND THE ARTERIAL NEEDLE DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24108519 ↗
• MalfunctionDec 29, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED A PATIENT UNDERWENT CORONARY ANGIOGRAPHY IN THE CATHETERIZATION LAB, DURING WHICH THE DOCTOR FOUND THAT THE PRESSURE SENSOR MEASUREMENT WAS INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23916970 ↗
• MalfunctionDec 23, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT AFTER A DOCTOR REPLACED THE PRESSURE SENSOR, LIQUID WAS FOUND LEAKING AT THE CONNECTION. UPON INSPECTION, A CRACK WAS FOUND AT THE PRESSURE SENSOR JOINT. WHEN PRESSURE WAS APPLIED, LIQUID LEAKED FROM THE CRACKED END OF THE TUBING, AND THE PRESSURE SENSOR WAS IMMEDIATELY REPLACED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23879357 ↗
• MalfunctionDec 16, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING USE LEAKAGE WAS FOUND AT THE INTERFACE OF THE PRESSURE SENSOR AND ITS ACCESSORIES AND WAS THEREFORE REPLACED WITH NO FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23818817 ↗
• MalfunctionDec 4, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL HIP ARTHROPLASTY UNDER COMBINED SPINAL-EPIDURAL ANESTHESIA DUE TO AVASCULAR NECROSIS OF THE FEMORAL HEAD. A CATHETER WAS INSERTED INTO THE LEFT RADIAL ARTERY FOR PRESSURE MEASUREMENT. BLOOD LEAKAGE WAS DISCOVERED IN THE LEAD-AHEAD TUBING OF THE PRESSURE SENSOR AND ITS ACCESSORIES. UPON INSPECTION, LEAKAGE WAS FOUND AT THE CONNECTOR. THE PRESSURE SENSOR AND ITS ACCESSORIES WERE IMMEDIATELY REPLACED, AND THE PATIENT FUNCTIONED NORMALLY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PROCEDURE DID NOT INCREASE THE SURGICAL RISK. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720743 ↗
• MalfunctionDec 1, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE REPORT THAT CLINICAL FEEDBACK INDICATED THAT THE MEASUREMENT DATA WAS INACCURATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682430 ↗
• MalfunctionNov 26, 2025Pressure Problem; Pressure Problem

  IT WAS REPORTED THAT DURING WARD ROUNDS, IT WAS DISCOVERED THAT THERE WAS WATER ACCUMULATION IN THE SUCTION TUBE. AFTER RULING OUT OTHER FACTORS, IT WAS FOUND THAT THE PRESSURE SENSOR AND ITS ACCESSORY VALVE WERE NOT PROPERLY SEALED, CAUSING FLUID TO FLOW INTO THE AIRWAY CONNECTOR. THE PROBLEM WAS DETECTED PROMPTLY; THUS, THE PATIENT SUFFERED NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657091 ↗
• MalfunctionNov 25, 2025Pressure Problem; Pressure Problem

  IT WAS REPORT THAT IN THE INTENSIVE CARE UNIT, THE PRESSURE SENSOR WAS CONNECTED. WHEN FLUSHING THE ARTERIAL BACKFLOW, A LEAK IN THE PRESSURE SENSOR WAS FOUND. CAUSING NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23646553 ↗
• MalfunctionNov 24, 2025Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED THAT THE PATIENT NEEDED INVASIVE ARTERIAL BLOOD PRESSURE MONITORING DURING SURGERY. BUT THE BLOOD PRESSURE COULD NOT BE MEASURED, AND AFTER REPLACING IT WITH A NEW ONE, IT COULD BE MEASURED NORMALLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23638796 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K942377. One submission often covers many models, so check the product and lot details in each record.

• Z-0185-2025 · Sep 24, 2024 · Open, Classified
  medex TRANSTAR MONITORING KIT 1/EA, Product Code REF MX20103R1
• Z-0186-2025 · Sep 24, 2024 · Open, Classified
  medex TranStar Kit w/ Stopcock1/EA, Product Code REF MX20740
• Z-0184-2025 · Sep 24, 2024 · Open, Classified
  medex NICU Monitoring Kit Set 1/EA, Product Code REF MX20086