Medex MX4345LMRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10351688507594), received between Jun 19, 2017 and Jul 31, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Crack” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2026Crack

  It was reported that during therapy, the manifold was cracked and begin to leak. This issue which resulted in critically ill and unstable decompensating, also BP drastically dropping and nearly coding for the patient, including possible exposure to the drug. The manifold was replaced and Epinephrine was administered to stabilize the patient. There was patient involvement and harm was reported.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50101319 ↗
• InjuryJun 28, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT PRESSOR MEDICATION STOPPED INFUSING DURING USE OF A MEDEX¿ LARGE BORE - HI-FLO¿ STOPCOCK. THE CARDIOVASCULAR ICU PATIENT WAS ON MULTIPLE PRESSOR MEDICATIONS RUNNING THROUGH A FIVE GANG STOPCOCK SETUP CONNECTED TO AN INTRODUCER SIDE ARM VIA ANOTHER SINGLE STOPCOCK ATTACHMENT. THE PATIENT, IMMEDIATELY AFTER BEING TURNED, BECAME ACUTELY HYPOTENSIVE: SYSTOLIC BLOOD PRESSURE (SBP) FELL FROM 70S TO 50S OVER A 15 MINUTE TIME FRAME. THE NURSE INCREASED PRESSOR DOSES BY SIGNIFICANT AMOUNTS. THE PATIENT WAS ALSO ON CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT), AND RESCUE FLUID WAS INFUSED AND PEAK FLOW RATE TURNED TO 0. PATIENT WAS BEING A-PACED WITH TEMPORARY PACEMAKER UP TO A RATE OF 90 AND IABP ADVANCE FROM 1:2 TO 1:1, ALL WITH LITTLE TO NO EFFECT. THE PATIENT'S DOCTOR AND INTENSIVIST DOCTOR WAS MADE AWARE AND BOTH CAME TO THE PATIENT'S BEDSIDE. NEO BOLUS WAS GIVEN BY THE INTENSIVIST DOCTOR. THE NURSE DOUBLE CHECKED INFUSING LINES AND FOUND THAT NONE OF THE PRESSOR MEDICATIONS WERE INFUSING. INTO THE PATIENT, BUT INSTEAD, OR WETTING THE BED. THE FIVE GANG STOPCOCK BECAME STRIPPED AND BROKE OFF. THE SINGLE STOPCOCK ATTACHED TO THE INTRODUCER SIDE ARM. THERE WAS NO BLOOD

  Patient problems: Bradycardia

  MAUDE report 6674914 ↗
• InjuryJun 19, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT "18 POST CARDIAC SURGERY", THE PATIENT EXPERIENCED AN AIR EMBOLISM DURING USE OF A MEDEX¿ LARGE BORE - HI-FLO¿ STOPCOCK. IT WAS OBSERVED THAT THE MANIFOLD SHOWED NO LEAKS, THE STOPCOCK WAS IN THE "OFF" POSITION, AND THE CAPS WERE TIGHTENED. ADDITIONAL INFORMATION REGARDING THE EVENT AND THE PATIENT'S CURRENT CONDITION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

  Patient problems: Air Embolism

  MAUDE report 6651185 ↗