Medex MX9341LRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 10351688504173), received between Apr 25, 2019 and Sep 24, 2026 — classified as 9 injuries, 54 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (41 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break; Fluid/Blood Leak

  It was reported that, upon evaluation of the additionally received Medex Stopcocks, cracking was observed along the A-port shafts of the returned device. The reported defect was confirmed. There was patient involvement and moderate patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50883606 ↗
• InjuryAug 11, 2026Crack; Fluid/Blood Leak

  It was reported that while using the 4-way stopcock the Leur lock connector was cracked and resulted in the patient not receiving the appropriate amount of infusion medication. It was stated that patient was receiving medication for sedation and it was leaked. So, the patient began to wake up. Patient was extremely sick. The nurse didn¿t realize the product had cracked and that the med was leaking into the bed, it took several minutes before the nurse realized what was happening. And then there was a delay with care while the nurse replaced the product. The patient temporarily had a decrease in the level of sedation thus requiring higher doses of medications being infused the nurse as well had to quickly find alternative access for the infusions while the replacement product was being prepared. There were patient involvement and harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50213824 ↗
• MalfunctionJul 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052304 ↗
• MalfunctionJul 28, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50052303 ↗
• MalfunctionJul 27, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017222 ↗
• MalfunctionJul 27, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017115 ↗
• MalfunctionJul 27, 2026Contamination

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017096 ↗
• MalfunctionJul 27, 2026Fluid/Blood Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017043 ↗
• MalfunctionJul 7, 2026Particulates

  IT WAS REPORTED THAT THE INFUSION, BLOOD WAS OBSERVED BACKING UP THROUGH THE INTRAVENOUS LINE BEYOND THE IN-LINE FILTER. EXAMINATION OF THE DEVICES REVEALED A PIECE OF PLASTIC LODGED WITHIN THE STOPCOCK, WHICH MAY HAVE CONTRIBUTED TO AN OCCLUSION. THE ISSUE WAS RESOLVED BY REPLACING THE STOPCOCK AND THE EXTENSION TUBING WITH THE FILTER. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25737127 ↗
• MalfunctionJun 4, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE FOUR-WAY STOPCOCKS DEVELOPING CRACKS IN THE PLASTIC AND LEAKING FLUIDS. THERE WAS PATIENT INVOLVEMENT WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25394831 ↗
• MalfunctionMay 11, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT WAS FOUND TO HAVE BLOOD LEAKING ONTO PILLOW BY THE RN. WHEN TRACED BACK IT WAS FOUND THAT IV FLUID AND BLOOD WAS COMING FROM CRACKED STOPCOCK WHERE NEEDLELESS LUER LOCK DEVICE CONNECTS INTO. THE SETUP WAS QUICKLY CHANGED, AND WITHIN 10 MINUTES THE SAME THING WAS WITNESSED TO BE HAPPENING, THE STOPCOCK WAS CRACKED WHERE THE LUER LOCK CONNECTS INTO. THIS WAS AGAIN CHANGED, AND WITHIN 5 MINUTES BLOOD AND IV GTT STARTED LEAKING OUT OF THE CRACKED STOPCOCK. THIS HAPPENED A TOTAL OF FOUR TIMES, EVENTUALLY THE IV TUBING WAS CONNECTED DIRECTLY TO THE STOPCOCK, NO FURTHER LEAKING OR BACK UP OF BLOOD OCCURRED. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25137248 ↗
• MalfunctionMay 4, 2026Fluid/Blood Leak

  AN EVENT INVOLVING STOPCOCKS WAS REPORTED IN WHICH THE STOPCOCK WAS LEAKING. SUCH LEAKAGE COULD POTENTIALLY EXPOSE THE PATIENT AND/OR CLINICIAN TO BLOOD OR MEDICATION. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25068164 ↗
• InjuryApr 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS BLOOD NOTED AND VASOPRESSOR MEDICATION LEAKING FROM STOPCOCK BRIDGE ATTACHED TO CVC LUMEN. THE CONNECTIONS WERE CHECKED AND TIGHTENING ATTEMPTED. IT CONTINUED TO LEAK AND BACK FLOWED BLOOD. MANIFOLD QUICKLY PRIMED AND MEDICATIONS REATTACHED. THE PATIENT WAS ON MULTIPLE VASOPRESSOR INFUSIONS TO MAINTAIN BLOOD PRESSURE. FOLLOWING PRODUCT FAILURE, THE PATIENT (CRITICALLY ILL AND ADMITTED TO A CRITICAL CARE UNIT) HAD A SUBSTANTIAL DROP IN BLOOD PRESSURE AND THE RN NOTED THAT BLOOD AND MEDICATIONS WERE LEAKING FROM THE STOPCOCK. NO ATTEMPT TO MITIGATE THE LIGATE WAS SUCCESSFUL SO THE RN SWITCHED TO A DIFFERENT BRAND¿S MANIFOLD. BLOOD PRESSURE WAS MANAGED WITH EMERGENCY MEDICATIONS SUCH AS PHENYLEPHRINE UNTIL THE VASOPRESSOR INFUSIONS COULD BE RE-ESTABLISHED THROUGH THE MANIFOLD. THIS WAS A PERI- CARDIAC ARREST SITUATION. THERE WAS PATIENT INVOLVEMENT AND HARM REPORTED.

  Patient problems: Cardiac Arrest; Low Blood Pressure/ Hypotension; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24839352 ↗
• MalfunctionApr 6, 2026Leak/Splash

  IT WAS REPORTED THAT THE PATIENT'S RIGHT BRACHIAL PICC LINE WAS NOTED TO BE LEAKING. AFTER FURTHER ASSESSMENT, IT WAS NOTED THAT THE EXTENSION PIECE OF THE CVP WAS DAMAGED AND CRACKED. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794375 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK WAS CRACKING AND LEAKING DURING USE. THE FAULT OCCURRED EVERY TIME THE DEVICE WAS USED WITH A PATIENT, AND IT RESULTED IN HARM, SPECIFICALLY CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION). A REPLACEMENT STOPCOCK HAD TO BE USED EACH TIME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663168 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK WAS CRACKING AND LEAKING DURING USE. THE FAULT OCCURRED EVERY TIME THE DEVICE WAS USED WITH A PATIENT, AND IT RESULTED IN HARM, SPECIFICALLY CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION). A REPLACEMENT STOPCOCK HAD TO BE USED EACH TIME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663104 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK WAS CRACKING AND LEAKING DURING USE. THE FAULT OCCURRED EVERY TIME THE DEVICE WAS USED WITH A PATIENT, AND IT RESULTED IN HARM, SPECIFICALLY CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION). A REPLACEMENT STOPCOCK HAD TO BE USED EACH TIME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663090 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK WAS CRACKING AND LEAKING DURING USE. THE FAULT OCCURRED EVERY TIME THE DEVICE WAS USED WITH A PATIENT, AND IT RESULTED IN HARM, SPECIFICALLY CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION). A REPLACEMENT STOPCOCK HAD TO BE USED EACH TIME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663078 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK WAS CRACKING AND LEAKING DURING USE. THE FAULT OCCURRED EVERY TIME THE DEVICE WAS USED WITH A PATIENT, AND IT RESULTED IN HARM, SPECIFICALLY CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION). A REPLACEMENT STOPCOCK HAD TO BE USED EACH TIME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24663011 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK WAS CRACKING AND LEAKING DURING USE. THE FAULT OCCURRED EVERY TIME THE DEVICE WAS USED WITH A PATIENT, AND IT RESULTED IN HARM, SPECIFICALLY CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION). A REPLACEMENT STOPCOCK HAD TO BE USED EACH TIME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662958 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK WAS CRACKING AND LEAKING DURING USE. THE FAULT OCCURRED EVERY TIME THE DEVICE WAS USED WITH A PATIENT, AND IT RESULTED IN HARM, SPECIFICALLY CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION). A REPLACEMENT STOPCOCK HAD TO BE USED EACH TIME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662938 ↗
• MalfunctionMar 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK WAS CRACKING AND LEAKING DURING USE. THE FAULT OCCURRED EVERY TIME THE DEVICE WAS USED WITH A PATIENT, AND IT RESULTED IN HARM, SPECIFICALLY CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION). A REPLACEMENT STOPCOCK HAD TO BE USED EACH TIME. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24662921 ↗
• MalfunctionMar 20, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT CRACKING AND LEAKING OCCURRED DURING INFUSION. THERE WAS PATIENT INVOLVEMENT, AND PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24649141 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS STATED THAT CRACKING AND LEAKING OCCURRED DURING USE. THE PROCEDURE STOPCOCK IS BEING USED FOR WHEN THE ISSUES OCCURRED WAS DURING INFUSION. THE FAULT OCCURRED EVERY TIME THE DEVICE WAS USED WITH A PATIENT, AND IT RESULTED IN HARM, SPECIFICALLY CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION). THERE WERE PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: Unspecified Infection

  MAUDE report 24629535 ↗
• MalfunctionMar 18, 2026Fluid/Blood Leak

  IT WAS STATED THAT CRACKING AND LEAKING OCCURRED DURING USE. THE PROCEDURE STOPCOCK IS BEING USED FOR WHEN THE ISSUES OCCURRED WAS DURING INFUSION. THE FAULT OCCURRED EVERY TIME THE DEVICE WAS USED WITH A PATIENT, AND IT RESULTED IN HARM, SPECIFICALLY CLABSI (CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION). THERE WERE PATIENT INVOLVEMENT AND PATIENT HARM.

  Patient problems: Unspecified Infection

  MAUDE report 24626172 ↗