Medex MX934Z4LMRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688504142), received between Jun 13, 2018 and Jun 13, 2018 — classified as 2 injuries.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 13, 2018Crack; Insufficient Flow or Under Infusion; Crack; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE AREA WHERE THE MEDEX¿ MANIFOLD CONNECTS TO SWAN WAS CRACKED. IT WAS "NOTED THAT PATIENT'S BLOOD PRESSURES WERE VERY LOW AND DROPPING DURING CHANGE OF SHIFT REPORT. PATIENT GIVEN ALBUMIN BY DAY RN; PATIENT PLACED INTO TRENDELENBURG POSITION. PRESSURES DOWN TO 60 OVER 40'S AND LOWER. HEART RATE DROPPING. NOTED WHILE MOVING PATIENT AND DIRECTLY CHECKING LINES THAT MANIFOLD HAD BLOOD BACKING UP THROUGH ALMOST TO WHERE IV TUBING WAS CONNECTED ON OTHER SIDE. NOTED WET AREA ON BEDDING, MIX OF BLOOD AND IV FLUIDS. THE MANIFOLD WAS IN PLACE FOR 2 DAYS." IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: Bradycardia; Low Blood Pressure/ Hypotension

  MAUDE report 7598387 ↗
• InjuryJun 13, 2018Crack; Insufficient Flow or Under Infusion; Crack; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT THE SECOND MANIFOLD, A MEDEX¿ MANIFOLD, AFTER 2 TO 3 HOURS, OF USE ALSO HAD CRACKED AT CAP SIDE CONNECTION. INTRAVENOUS FLUIDS AND VASOPRESSORS LEAKED ALL OVER THE BED AND PATIENT HAD LOSS OF HEMODYNAMIC VITALS. PATIENT HAD TO BE PLACED INTO TRENDELENBURG POSITION AGAIN WITH INCREASE OF DROPS (GTT). IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS OCCURRENCE.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 7598330 ↗