Medex MX9605ARecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10351688502919), received between Sep 11, 2022 and Sep 13, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747125 ↗
• MalfunctionSep 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747124 ↗
• MalfunctionSep 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747121 ↗
• MalfunctionSep 13, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50747120 ↗
• MalfunctionDec 13, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE IN THE PREOPERATIVE PREPARATION ROOM, THE DOCTOR USED A PRESSURE SENSOR AND ITS ACCESSORIES TO PERFORM INVASIVE ARTERIAL MONITORING ON THE PATIENT. AFTER 3 MINUTES OF USE, THE PRESSURE SENSOR WAS FOUND TO BE LEAKING. UPON INSPECTION, CRACKS WERE FOUND ON THE PIPELINES OF THE PRESSURE SENSOR AND ITS ACCESSORIES. A NEW PRESSURE SENSOR AND ITS ACCESSORIES WERE IMMEDIATELY REPLACED, AND NO ABNORMALITIES WERE FOUND. DUE TO THE REPLACEMENT OF THE NEW PRESSURE SENSOR AND ITS ACCESSORIES, THE PATIENT'S SURGERY TIME WAS DELAYED BY ABOUT 5 MINUTES. FORTUNATELY, THE PRESSURE SENSOR LEAKAGE WAS DISCOVERED IN TIME, OTHERWISE IT WOULD AFFECT THE PATIENT'S MONITORED BLOOD PRESSURE VALUE AND AFFECT THE DOCTOR'S JUDGMENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20927361 ↗
• MalfunctionSep 11, 2022Complete Blockage; Blocked Connection; Complete Blockage; Blocked Connection

  IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO FLUSH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397892 ↗

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