Medex MX43660Recalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 10351688507563), received between Aug 18, 2020 and Sep 22, 2026 — classified as 4 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (17 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 27 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Separation Problem

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50861391 ↗
• MalfunctionSep 22, 2026Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859868 ↗
• MalfunctionSep 22, 2026Separation Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50859789 ↗
• InjuryFeb 23, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING ECMO [EXTRACORPOREAL MEMBRANE OXYGENATION] PROCEDURE, THE PIGTAIL TUBING FOR CLOTS OR FIBRINS AND TUBE SNAPED OFF AT THE LEUR LOCK OF THE ECMO CIRCUIT. THE ECMO CIRCUIT WAS BRIEFLY CLAPPED OFF TO REPLACE TUBING. THE PATIENT LOST BLOOD AND LATER HAD TO BE TRANSFUSED ONE UNIT TO REPLACE BLOOD LOST DURING INCIDENT. PATIENT WAS HYPOTENSIVE AND BEING SUPPORTED ON VASOPRESSORS. BOTH INFLOW AND RETURN CANNULAS WERE CLAMPED OFF <10 SECONDS IN ORDER TO REPLACE PIGTAIL TUBING. FLOWS ON ECMO REESTABLISHED WITHIN 30 SECONDS AND ABLE TO COME OFF OF VASOPRESSORS. THE EVENT OCCURRED IN THE HOSPITAL. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS PATIENT HARM REPORTED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 24414215 ↗
• MalfunctionFeb 17, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LINE KEPT BREAKING AND RESULTED IN BLOOD LOSS. ADDITIONAL UNSPECIFIED INTERVENTIONS AND MONITORING REQUIRED. THE EVENT OCCURRED DURING SET UP TO CHANGE THE EXTENSION THAT BROKE. THERE WAS NO PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370009 ↗
• MalfunctionFeb 17, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LINE REPEATEDLY BROKE, RESULTING IN BLOOD LOSS. THE EVENT OCCURRED DURING INFUSION AND MONITORING AND REQUIRED ADDITIONAL MONITORING AND UNSPECIFIED INTERVENTIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369885 ↗
• MalfunctionFeb 17, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LINE REPEATEDLY BROKE, RESULTING IN BLOOD LOSS. THE EVENT OCCURRED DURING INFUSION AND MONITORING AND REQUIRED ADDITIONAL MONITORING AND UNSPECIFIED INTERVENTIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369636 ↗
• MalfunctionFeb 17, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LINE REPEATEDLY BROKE, RESULTING IN BLOOD LOSS. THE EVENT OCCURRED DURING INFUSION AND MONITORING AND REQUIRED ADDITIONAL MONITORING AND UNSPECIFIED INTERVENTIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369247 ↗
• MalfunctionFeb 17, 2026Fluid/Blood Leak

  IT WAS STATED THAT THE LINE KEPT BREAKING AND RESULTED IN BLOOD LOSS. THE EVENT OCCURRED DURING INFUSION AND MONITORING. THE EVENT OCCURRED AT CTICU AND ADDITIONAL INTERVENTIONS AND MONITORING REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369039 ↗
• MalfunctionFeb 17, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LINE REPEATEDLY BROKE, RESULTING IN BLOOD LOSS. THE EVENT OCCURRED DURING INFUSION, MONITORING, AND UNSPECIFIED INTERVENTIONS, AND REQUIRED ADDITIONAL MONITORING AND UNSPECIFIED INTERVENTIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369022 ↗
• MalfunctionFeb 17, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LINE REPEATEDLY BROKE, RESULTING IN BLOOD LOSS. THE EVENT OCCURRED DURING INFUSION, MONITORING, AND UNSPECIFIED INTERVENTIONS, AND REQUIRED ADDITIONAL MONITORING AND UNSPECIFIED INTERVENTIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368819 ↗
• MalfunctionFeb 17, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LINE REPEATEDLY BROKE, RESULTING IN BLOOD LOSS. THE EVENT OCCURRED DURING INFUSION, MONITORING, AND INTERVENTIONS, AND REQUIRED ADDITIONAL MONITORING AND INTERVENTIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368482 ↗
• MalfunctionFeb 17, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE LINE REPEATEDLY BROKE, RESULTING IN BLOOD LOSS. THE EVENT OCCURRED DURING INFUSION, MONITORING, AND INTERVENTIONS, AND REQUIRED ADDITIONAL MONITORING AND INTERVENTIONS. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24368423 ↗
• MalfunctionFeb 9, 2026Break

  IT WAS REPORTED THAT THE LINE KEPT BREAKING AND RESULTED IN BLOOD LOSS. THERE WAS REPORTED PATIENT INVOLVEMENT AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24299514 ↗
• MalfunctionJan 26, 2026Fluid/Blood Leak; Fracture

  IT WAS REPORTED THAT UPON INSPECTION IT WAS NOTICED THE ACTUAL A-LINE TUBING WAS LEAKING SMALL AMOUNT OF BLOOD. WHILE CHANGING THE TUBING, THE TUBING COMPLETELY RIPPED IN HALF. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24184402 ↗
• MalfunctionJan 22, 2026Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE TUBING ON THE STOPCOCK SNAPPED. THE PATIENT EXPERIENCED BLEEDING FROM THE ARTERIAL LINE AS A RESULT OF THIS DEFECTIVE PRODUCT. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24146350 ↗
• MalfunctionJan 19, 2026Disconnection

  IT WAS REPORTED THAT A LINE CLEAR TUBING DISCONNECTED OR DISLODGED FROM WHERE IT WAS GLUED INTO THREE-WAY STOPCOCK ON THE PATIENT SIDE. NURSE AT THE TIME OF EVENT CLAMPED LINE QUICKLY AFTER NOTING BLEEDING. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24111455 ↗
• MalfunctionMay 2, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE THREE-WAY STOPCOCKS ON THE A-LINES CAUSED MULTIPLE DISCONNECTIONS FROM THE A-LINES. THE CONNECTION WAS NOT SECURE ENOUGH AND COULD NOT BE MADE MORE SECURE LEADING TO DISCONNECTION. THE OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21950753 ↗
• MalfunctionFeb 19, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT AFTER APPROXIMATELY ONE HOUR OF INFUSION, THE NURSE NOTED THE 3-WAY STOP COCK TO BE CRACKED ON THE LEVOPHED SIDE. PATIENT WAS NOTED TO HAVE HEMODYNAMIC INSTABILITY WHICH REQUIRED FREQUENT TITRATION UP AND DOWN OF LEVOPHED. THERE WERE UNKNOWN PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21416996 ↗
• MalfunctionFeb 7, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CARDIOVASCULAR INTENSIVE CARE UNIT EXPERIENCED FOUR INSTANCES OVER A FEW DAYS WHERE THE DEVICE BROKE AT THE CONNECTION BETWEEN THE TUBING PIGTAIL AND THE 3-WAY STOPCOCK. THESE BREAKS RESULTED IN BLOOD SPILLS ON THE PATIENT, THEIR BEDS, AND THE FLOORS. THE EVENT OCCURRED ON (B)(6) 2025 AT 5 PM DURING USE ON THE PATIENT. THERE WAS MEDICATION BEING USED WITH THE PRODUCT AND THERE WAS DELAY IN THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21335250 ↗
• MalfunctionFeb 7, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CARDIOVASCULAR INTENSIVE CARE UNIT EXPERIENCED FOUR INSTANCES OVER A FEW DAYS WHERE THE DEVICE BROKE AT THE CONNECTION BETWEEN THE TUBING PIGTAIL AND THE 3-WAY STOPCOCK. THESE BREAKS RESULTED IN BLOOD SPILLS ON THE PATIENT, THEIR BEDS, AND THE FLOORS. THE EVENT OCCURRED ON (B)(6) 2025 AT 5 PM DURING USE ON THE PATIENT. THERE WAS MEDICATION BEING USED WITH THE PRODUCT AND THERE WAS DELAY IN THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21335241 ↗
• MalfunctionFeb 7, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CARDIOVASCULAR INTENSIVE CARE UNIT EXPERIENCED FOUR INSTANCES OVER A FEW DAYS WHERE THE DEVICE BROKE AT THE CONNECTION BETWEEN THE TUBING PIGTAIL AND THE 3-WAY STOPCOCK. THESE BREAKS RESULTED IN BLOOD SPILLS ON THE PATIENT, THEIR BEDS, AND THE FLOORS. THE EVENT OCCURRED ON (B)(6) 2025 AT 5 PM DURING USE ON THE PATIENT. THERE WAS MEDICATION BEING USED WITH THE PRODUCT AND THERE WAS DELAY IN THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21335231 ↗
• MalfunctionFeb 7, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THE THREE-WAY STOPCOCKS ON THE A-LINES CAUSED MULTIPLE DISCONNECTIONS FROM THE A-LINES. THE CONNECTION WAS NOT SECURE ENOUGH AND COULD NOT BE MADE MORE SECURE LEADING TO DISCONNECTION. THE OPERATOR OF DEVICE WAS A HEALTH PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333501 ↗
• MalfunctionFeb 7, 2025Break; Fluid/Blood Leak; Break; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CARDIOVASCULAR INTENSIVE CARE UNIT EXPERIENCED FOUR INSTANCES OVER A FEW DAYS WHERE THE DEVICE BROKE AT THE CONNECTION BETWEEN THE TUBING PIGTAIL AND THE 3-WAY STOPCOCK. THESE BREAKS RESULTED IN BLOOD SPILLS ON THE PATIENT, THEIR BEDS, AND THE FLOORS. THE EVENT OCCURRED ON (B)(6) 2025 AT 5 PM DURING USE ON THE PATIENT. THERE WAS MEDICATION BEING USED WITH THE PRODUCT AND THERE WAS DELAY IN THERAPY. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21333471 ↗
• MalfunctionJan 20, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THERE WERE 6 INSTANCES OF A LINE THAT SLIPPED AND DISCONNECTED THAT RESULTED IN PATIENTS BLEEDING. THE DEVICE IS UNKNOWN IF AVAILABLE FOR INVESTIGATION. THERE WAS PATIENT INVOLVEMENT. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21193051 ↗