Medex MX5341LRecalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10351688506788), received between Aug 4, 2022 and Jun 19, 2026 — classified as 3 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (13 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 19, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT¿S BLOOD PRESSURE SUDDENLY DROPPED TO 60/20, CONFIRMED BY BOTH NON-INVASIVE BLOOD PRESSURE AND ARTERIAL LINE READINGS. IT WAS FOUND THAT THE STOPCOCK DELIVERING NOREPINEPHRINE, VASOPRESSIN, AND DOBUTAMINE HAD DISCONNECTED FROM THE ONE-LINK IV CONNECTOR AT THE CENTRAL LINE. AFTER REATTACHMENT AND INCREASING NOREPINEPHRINE, THE PATIENT IMPROVED QUICKLY. INSTABILITY HAD BEEN OBSERVED WITH THE STOPCOCK¿ONE-LINK CONNECTION. THE CONNECTOR HAS SHORT THREADS AND SIGNIFICANT BACK PRESSURE, MAKING IT PRONE TO LOOSENING. THERE WAS PATIENT INVOLVEMENT WITH NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25566536 ↗
• MalfunctionJun 15, 2026Disconnection

  IT WAS REPORTED THAT TWO STOPCOCKS CONNECTED IN SERIES BECAME DISCONNECTED DURING PATIENT TURN, RESULTING IN AN INTERRUPTION OF VASOPRESSOR INFUSION (NOREPINEPHRINE). FOLLOWING THE DISCONNECTION, THE PATIENT EXPERIENCED A DECREASE IN MEAN ARTERIAL PRESSURE (MAP) AND A SUBSEQUENT DROP IN GLASGOW COMA SCALE (GCS). AT THE TIME OF THE EVENT, THE PATIENT DID NOT HAVE AN ARTERIAL LINE IN PLACE FOR CONTINUOUS BLOOD PRESSURE MONITORING. AS A RESULT, THE HYPOTENSIVE EPISODE WAS NOT IMMEDIATELY RECOGNIZED AND WAS ONLY IDENTIFIED WHEN THE NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR CYCLED APPROXIMATELY 15 MINUTES LATER. THERE WERE PATIENT INVOLVEMENT AND NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25512081 ↗
• MalfunctionMay 27, 2026Backflow; Disconnection

  IT WAS REPORTED THAT DURING ROUTINE PATIENT CARE A SMALL-BORE STOPCOCK HAD AN ISSUE INVOLVING INTRAVENOUS LINE CONNECTIONS. UPON ASSESSMENT PROMPTED BY OBSERVED LOW BLOOD PRESSURE READINGS, IT WAS DISCOVERED THAT THE SEDATION LINE HAD BECOME DISCONNECTED. APPROXIMATELY 10 ML OF BLOOD WAS NOTED ON THE PATIENT¿S BED AT THE TIME OF DISCOVERY. THE SITE REPRESENTATIVE ENSURED ALL LINES WERE INSPECTED AND RESECURED APPROPRIATELY AND NEW STOPCOCKS WERE PRIMED AND CONNECTED TO MAINTAIN PROPER LINE INTEGRITY. SEDATION AND EPINEPHRINE THERAPY WAS BEING ADMINISTERED DURING THE EVENT. THE PATIENT HAD DECREASED BLOOD PRESSURE AND NEEDED ANOTHER LINEN CHANGE AND THERE WAS LOSS OF BLOOD VOLUME AT TIME OF OCCURRENCE. FURTHER, THE PATIENT WAS STABILIZED ONCE STOPCOCK WAS REPLACED. THERE WAS PATIENT INVOLVEMENT, AND NO HARM.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 25302422 ↗
• MalfunctionMay 20, 2026Disconnection; Fluid/Blood Leak

  IT WAS REPORTED THAT, DURING ROUTINE PATIENT CARE, THE PATIENT WAS TRANSFERRED FROM TUMBLE FOAM TO THE HOSPITAL BED AND DURING THIS TRANSFER, THE CLINICIAN OBSERVED THAT THE PATIENT¿S MAINTENANCE INTRAVENOUS (IV) FLUID TUBING WAS DETACHED AT THE STOPCOCK CONNECTION AND WAS LYING ON THE BED. PER REPORTER, THE INTRAVENOUS INFUSION WAS IMMEDIATELY STOPPED UPON DISCOVERY OF THE DISCONNECTION. A NEW INTRAVENOUS TUBING LINE WAS PRIMED AND CONNECTED. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25231999 ↗
• MalfunctionMay 15, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE NURSE ENTERED THE PATIENT'S ROOM AND OBSERVED THE PATIENT¿S BED SHEETS WERE SIGNIFICANTLY WET. UPON INSPECTION, THE DEVICE WAS OBSERVED DISCONNECTED FROM THE HUB OF ONE LUMEN OF THE PATIENT¿S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE, THAT RESULTED IN IV FLUID LEAKAGE. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25186703 ↗
• MalfunctionApr 22, 2026Failure to Infuse

  IT WAS REPORTED THAT STOPCOCKS ARE FREQUENTLY DISCONNECTING FROM LINE AND ARE UNABLE TO BE SECURED TO LINE DURING INFUSION. THERE WAS DELAY OF 5 TO 10 MINUTES IN THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24954882 ↗
• MalfunctionApr 16, 2026Fluid/Blood Leak; Fracture

  IT WAS STATED THAT THE STOPCOCK WAS ON A UVC LINE AND WAS FOUND LEAKING AT THE CONNECTION. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24900929 ↗
• MalfunctionMar 24, 2026Disconnection

  IT WAS REPORTED THAT THE STOPCOCK WAS DETACHED FROM THE CENTRAL VENOUS LINE WHILE RUNNING HIGH DOSE VASOPRESSOR. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. PER REPORTER, THE PATIENT'S BLOOD PRESSURE DROPPED.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 24682050 ↗
• MalfunctionMar 10, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STAFF WERE CALLED TO THE PATIENT¿S ROOM WHEN THE WRITER FOUND BLOOD BACKING UP IN THE LINE AND LEAKING ONTO THE SHEETS. THE WRITER PAUSED THE HEPARIN AND TACROLIMUS INFUSIONS AND DISCOVERED THAT THE EXTENSION PIECE HAD COME LOOSE AT THE STOPCOCK. THE REGISTERED NURSE TIGHTENED THE CONNECTION AND NOTIFIED THE CHARGE NURSE, WHO DECIDED THAT THE MICRO-EXTENSION PIECE AND STOPCOCK SHOULD BE REPLACED, WHILE THE REST OF THE LINE COULD BE KEPT. BLOOD RETURN AT THE CAP WAS OBSERVED AND WASTED, THE LINE WAS FLUSHED, AND THE NEW TUBING WAS CONNECTED. THE LINE INFUSED WITHOUT ANY ISSUES FOR THE REST OF THE NIGHT. THE PERSON AFFECTED WAS AN INPATIENT, INCLUDING THOSE UNDER OBSERVATION. NO HARM REACHED THE PATIENT, AND NO MONITORING WAS REQUIRED. THE MEDICATION INVOLVED WAS TACROLIMUS RUNNING AT 1.23 ML PER HOUR, AND IT WAS ORDERED, DISPENSED, AND ADMINISTERED AS PRESCRIBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24562692 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STAFF WERE CALLED TO THE PATIENT¿S ROOM WHEN THE WRITER FOUND BLOOD BACKING UP IN THE LINE AND LEAKING ONTO THE SHEETS. THE WRITER PAUSED THE HEPARIN AND TACROLIMUS INFUSIONS AND DISCOVERED THAT THE EXTENSION PIECE HAD COME LOOSE AT THE STOPCOCK. THE REGISTERED NURSE TIGHTENED THE CONNECTION AND NOTIFIED THE CHARGE NURSE, WHO DECIDED THAT THE MICRO-EXTENSION PIECE AND STOPCOCK SHOULD BE REPLACED, WHILE THE REST OF THE LINE COULD BE KEPT. BLOOD RETURN AT THE CAP WAS OBSERVED AND WASTED, THE LINE WAS FLUSHED, AND THE NEW TUBING WAS CONNECTED. THE LINE INFUSED WITHOUT ANY ISSUES FOR THE REST OF THE NIGHT. THE PERSON AFFECTED WAS AN INPATIENT, INCLUDING THOSE UNDER OBSERVATION. NO HARM REACHED THE PATIENT, AND NO MONITORING WAS REQUIRED. THE MEDICATION INVOLVED WAS TACROLIMUS RUNNING AT 1.23 ML PER HOUR, AND IT WAS ORDERED, DISPENSED, AND ADMINISTERED AS PRESCRIBED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24487840 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK WAS DISCONNECTED DURING THE NOREPINEPHRINE INFUSION. TWO NEW STOPCOCKS WERE REESTABLISHED. THERE WAS PATIENT INVOLVEMENT AND UNKNOWN PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24483018 ↗
• MalfunctionMar 2, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK'S LOCK POPPED OFF; THE NOREPINEPHRINE AND DOBUTAMINE LINES HAD DISCONNECTED FROM THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE AT THE CONNECTION BETWEEN THE TWO FOUR-WAY STOPCOCKS. THERE WAS MINIMAL TO NO LEAKAGE OR DRAINAGE ON THE SHEETS. THERE WERE PATIENT INVOLVEMENT AND NO REPORTED HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24482759 ↗
• InjuryFeb 20, 2026Disconnection

  IT WAS STATED THAT COMPLAINT (B)(6) FAILURE OF STOPCOCKS TO THREAD AND TIGHTEN, REMOVED AND REPLACED. A CRITICALLY ILL PATIENT ON SUBSTANTIAL VASOPRESSOR INFUSIONS BECAME ACUTELY HEMODYNAMICALLY UNSTABLE AND EXPERIENCED A PERI-ARREST SITUATION WITH A BLOOD PRESSURE OF 50/40. THE PATIENT WAS RESUSCITATED WITH EPINEPHRINE BOLUSES (A HIGH OCCURRENCE IN THE POST-OP CARDIAC SURGERY POPULATION) AND FLUID BOLUSES (THE PATIENT WAS FLUID-OVERLOADED AND ON CONTINUOUS DIALYSIS). IT WAS DISCOVERED THAT THE LINE HAD DISCONNECTED AT THE STOPCOCK, AND THE INFUSED MEDICATIONS WERE NOT BEING ADMINISTERED TO THE PATIENT. THE INVOLVED PARTIES ATTEMPTED TO RECONNECT THE LINE, BUT THE STOPCOCKS WOULD NOT THREAD ONTO EACH OTHER AND KEPT FALLING APART.

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

  MAUDE report 24405769 ↗
• InjuryFeb 20, 2026Disconnection

  IT WAS STATED THAT COMPLAINT 57001 FAILURE OF STOPCOCKS TO THREAD AND TIGHTEN, REMOVED AND REPLACED. A CRITICALLY ILL PATIENT ON SUBSTANTIAL VASOPRESSOR INFUSIONS BECAME ACUTELY HEMODYNAMICALLY UNSTABLE AND EXPERIENCED A PERI-ARREST SITUATION WITH A BLOOD PRESSURE OF 50/40. THE PATIENT WAS RESUSCITATED WITH EPINEPHRINE BOLUSES (A HIGH OCCURRENCE IN THE POST-OP CARDIAC SURGERY POPULATION) AND FLUID BOLUSES (THE PATIENT WAS FLUID-OVERLOADED AND ON CONTINUOUS DIALYSIS). IT WAS DISCOVERED THAT THE LINE HAD DISCONNECTED AT THE STOPCOCK, AND THE INFUSED MEDICATIONS WERE NOT BEING ADMINISTERED TO THE PATIENT. THE INVOLVED PARTIES ATTEMPTED TO RECONNECT THE LINE, BUT THE STOPCOCKS WOULD NOT THREAD ONTO EACH OTHER AND KEPT FALLING APART.

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

  MAUDE report 24405737 ↗
• InjuryJan 26, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE STOPCOCK WAS DISCONNECTED FROM TUBING, CREATING LARGE AMOUNT OF BLOOD MEASURED 37 MILLILITERS TO POOL ON THE BED. PATIENT REQUIRED BLOOD TRANSFUSION AND HAD A PULMONARY HEMORRHAGE LATER THAT DAY. THE EVENT OCCURRED WHILE IN USE WITH PATIENT IN THE PICU. THERE WAS PATIENT INVOLVEMENT AND PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24177473 ↗
• MalfunctionNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT UPON ASSESSMENT, STOPCOCK ON LUMEN 1 OF THE PATIENT'S IJ WAS DETACHED AND PATIENT WAS BLEEDING INTO BED. NO AIR WAS VISIBLE IN THE LINE. THERE WAS A PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657714 ↗
• MalfunctionNov 25, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT PATIENT¿S LINE HAD COME APART. UPON INSPECTION, THE NURSE OBSERVED THAT THE EXTENSION LINE HAD SPLIT AT THE CONNECTION POINT TO THE PLASTIC. THERE WAS LEAKAGE NOTED. THE PATIENT¿S CAPS WERE CHANGED, AND THE LINE WAS HEPARIN LOCKED. NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23645615 ↗
• MalfunctionOct 28, 2025Break; Break

  IT WAS REPORTED THAT THE STOPCOCK ON THE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT BROKE APART. THE PATIENT REMAINED INTUBATED AFTER UNDERGOING A LEFT CONGENITAL DIAPHRAGMATIC HERNIA REPAIR AND WAS SEDATED WHILE ON VENOARTERIAL ECMO, WHICH MAINTAINED THE TARGET FLOW RATES. THERE WERE NO ACUTE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23408177 ↗
• MalfunctionSep 5, 2025Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE PATIENT'S PARENTS CALLED THE NURSE INTO THE ROOM BECAUSE THEY SAW BLOOD BACKING UP INTO THE LINE FROM THE CENTRAL VENOUS CATHETER (CVC) RED LUMEN. UPON INSPECTION, THE LINE WAS INTACT, BUT BLOOD WAS SEEPING OUT OF THE CONNECTIONS AROUND THE STOPCOCK. THE LINE WAS CLAMPED, TUBING WAS DISCONNECTED, AND THE LINE WAS FLUSHED. CAP AND TUBING WERE CHANGED SINCE IT WAS DUE FOR A LINE CHANGE. THIS INCIDENT HAPPENED DURING A CEFEPIME INFUSION, THEN THE PROVIDER AND THE PHARMACIST WERE NOTIFIED. CEFEPIME WAS RE-DOSED. THERE WERE NO LEAKS, CUTS OR DEFECTS NOTED ON THE TUBING. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN SIGNS OR SYMPTOMS EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977041 ↗
• MalfunctionDec 6, 2024Disconnection; Disconnection

  IT WAS REPORTED THAT THE "STOPCOCK KEPT FALLING OFF IV'S; DISCONNECTED IV IN PATIENT'S BED WAS FOUND WITH BLOOD BACKING UP. IV WAS CLOTTED AND WAS UNABLE TO USE. THE IV WAS REMOVED AS IT WAS NOT FUNCTIONING BECAUSE THE INFUSION WAS NOT ATTACHED TO THE IV BECAUSE IT FELL OFF, NO NEW IV STARTED". THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860440 ↗
• MalfunctionDec 6, 2024Fluid/Blood Leak; Loose or Intermittent Connection; Fluid/Blood Leak; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE DEVICE'S CONNECTIONS CAME LOOSE, AND IV SOLUTION WAS LEAKING ONTO BED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20860018 ↗
• MalfunctionJul 1, 2024Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT PATIENT WITH PICC LINE FOR IV MEDICATION NOTICED FLUID DRIPPING FROM STOPCOCK. CRACK ON STOPCOCK WAS NOTED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19643980 ↗
• MalfunctionNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE "3 WAY STOPCOCK CAME OUT APART DURING CONTRAST PUMP INJECTION". ADVERSE EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18142795 ↗
• MalfunctionSep 15, 2023Crack; Fracture; Crack; Fracture

  IT WAS REPORTED THAT THERE WAS AN INCREASED PRESSER REQUIREMENT AND ESCALATION OF CARE. THE PATIENT WENT FOR EMERGENT COMPUTERIZED TOMOGRAPHY (CT), AND QUESTION OF WHETHER OR NOT GOING TO THE OPERATING ROOM (OR) AFTER. UPON RETURN FROM COMPUTERIZED TOMOGRAPHY (CT), IT WAS NOTICED THE PATIENTS GOWN WAS WET. IT APPEARED THE STOPCOCK HAD A CRACK IN IT AND WAS CHANGED IMMEDIATELY UPON INSPECTION. AFTER CHANGING THE STOPCOCK WITH THE PRESSERS ATTACHED, THE PATIENT BECAME HYPERTENSIVE, THUS DECREASING A LARGE NEED FOR THE PRESSERS.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17761105 ↗
• MalfunctionFeb 9, 2023Disconnection; Disconnection

  ADDITIONAL INFORMATION - FACILITY ADDRESS : (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16338072 ↗