VitalFlow Set 58112Recalls & reported problems
Michigan Critical Care Consultants, Inc. · The VitalFlow set contains components used to complete an extracorporeal circuit for ECMO procedures, including tubing assemblies, the Nautilus VF ECMO Oxygenator, and the VitalFlow Centrifugal Pump. The VitalFlow set contains a preassembled drainage and return loop “ECMO Circuit”, tubing assemblies, and other components used to prepare a basic extracorporeal circuit. The “Priming Circuit” contains components to supplement the basic extracorporeal circuit, as needed per hospital protocols for setting up the ECMO circuit. A venous reservoir and a one-way valve are included in the priming circuit to facilitate ease of priming the ECMO circuit. The Nautilus VF ECMO oxygenator with Balance Biosurface is used to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed. The VitalFlow Centrifugal Pump is designed to move blood by centrifugal force generated by a combination of a smooth rotating cone and low-profile impeller fins. Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump. To limit friction and heat generation, the VitalFlow centrifugal pump utilizes a pivot bearing design on a dual ceramic pivot. · Class 2
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10850007732339), received between Jan 8, 2025 and Sep 22, 2026 — classified as 2 injuries, 8 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak5
- Obstruction of Flow5
- Communication or Transmission Problem2
- Device Alarm System2
- Noise, Audible2
- Crack1
- Display or Visual Feedback Problem1
- Increase in Pressure1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Cardiogenic Shock1
- Gastrointestinal Hemorrhage1
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Obstruction of Flow
Patient problems: Cardiogenic Shock; Gastrointestinal Hemorrhage; No Clinical Signs, Symptoms or Conditions
MAUDE report 50856771 ↗MalfunctionAug 10, 2026Device Alarm System; Display or Visual Feedback Problem; Fluid/Blood Leak; Obstruction of Flow; Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50190173 ↗InjuryAug 7, 2026Obstruction of Flow
Medtronic received information that during use of a Vital flow tubing set, it was reported that the device had a flow/ clot issues. The biomed believes the device sucked a clot from the left ventricle of the patient into the pump head. Flow stopped and a hand crank was used for roughly 10 mins, and this provided some flow. Customer placed the cone back to the motor drive and was able to get some flow The customer believed the clot in the left ventricle of the heart became dislodged and migrated into the motor drive. The patient was previously on heparin, the issue did not worsen over time. The RPM at time of event was 3800, the flow at time of event- 0.33LPM, and the only blood loss was the blood in the clotted off circuit. Anticoagulation used Heparin 100 units/hr, not ACTs were collected, aPTT 40-50. Plasmalyte was used to prime the circuit. The location of this issue was at the cone and pre ox side of vital flow membrane oxygenator. The device was replaced to complete the procedure. There was no adverse patient effect associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50171911 ↗InjuryJul 31, 2026Obstruction of Flow; Communication or Transmission Problem; Noise, Audible
Medtronic received information that during use of a Vital flow set, it was reported that at initiation, the circuit was presented with E49 error code and an intermittent/unreliable pressure and saturation readings. After 4 days of support without patient support issues, the circuit suddenly went to zero flow with a loud rattling sounds emanated from the pump head. Pump was transitioned to hand crank and back to motor, and was able to achieve flow with loud rattle persisting. Pump went to zero flow once more and then a decision was made to perform an urgent circuit exchange. The device was replaced to complete the procedure. There was no adverse patient effect associated with this event.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50097281 ↗MalfunctionJul 28, 2026Fluid/Blood Leak
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 50060811 ↗MalfunctionMar 23, 2026Obstruction of Flow; Noise, Audible
IT WAS REPORTED THAT DURING USE, THE VITALFLOW TUBE SET PUMP EXHIBITED A GRINDING NOISE, PUMP FAILURE, AND THE PUMP STOPPED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24660556 ↗MalfunctionFeb 10, 2026Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A VITALFLOW SET, THE CUSTOMER REPORTED THAT THE OXYGENATOR HAD A LEAKING TUBING CONNECTION. THE DEVICE WAS REPLACED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24301923 ↗MalfunctionJan 8, 2026Fluid/Blood Leak
IT WAS REPORTED THAT A LEAK WAS IDENTIFIED ON THE OUTLET SIDE AT THE PINK PORT OF THE MC3 VITALFLOW NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR PRIOR TO USE. THERE WAS NO NOTED DAMAGE TO THE PACKAGING DURING SETUP, AND NO OTHER COMPONENTS WERE AFFECTED. THE SAME LEAK DID NOT APPEAR IN MULTIPLE PACKS. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE SERIAL NUMBER OF THE OXYGENATOR IS (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24001992 ↗MalfunctionNov 27, 2025Device Alarm System; Crack; Fluid/Blood Leak; Device Alarm System; Crack; Fluid/Blood Leak
IT WAS REPORTED THAT THE MC3 VITAL FLOW NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR EXPERIENCED AN UNRESOLVABLE OXYGENATOR FAILURE, WITH ERRORS E47 (OXY COMMUNICATION LOST) AND E49 (OXY ERROR - OUTLET BOARD) OCCURRING WHILE THE DEVICE WAS RUNNING IN PRIME MODE PRIOR TO PATIENT USE. THE E47 ERROR WAS OBSERVED ON A NEW CIRCUIT AFTER THE DEVICE INITIALLY FUNCTIONED APPROPRIATELY, OCCURRING APPROXIMATELY 12 HOURS AFTER PRIMING, AND WAS PRECEDED BY THE E49 ERROR. THEY LEAVE THEIR PRIMED BACKUP CONSOLES RUNNING IN PRIME MODE IN ORDER FOR A SPECIALIST TO DO CIRCUIT CHECKS DURING SHIFT. THEY QUICKLY RULED OUT BOTH CABLE AND CONSOLE AS THE SOURCE AND FOCUSED ON THE OXYGENATOR ITSELF. THEY WERE STORED IN A LOCKED PUMP ROOM. MOISTURE DROPLETS WERE OBSERVED IN THE OUTLET SENSOR HOUSING, AND FLUID WAS OBSERVED LEAKING FROM THE BOTTOM OF THE DEVICE WHEN IT WAS REMOVED FROM THE MOUNTING BRACKET. NO HEATER C OOLER WATER HOSES HAD BEEN CONNECTED, INDICATING THE FLUID ORIGINATED FROM PRIMING. ALTHOUGH NO VISIBLE EXTERNAL DAMAGE OR CRACKS WERE SEEN, MOISTURE WAS EVIDENT IN THE ARTERIAL SENSOR HOUSING, SUGGESTING A POSSIBLE CRACK, BREAK, OR HOLE AT THAT LOCATION. A COMPLETE CRACK/BR
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23666010 ↗MalfunctionJan 8, 2025Increase in Pressure; Increase in Pressure
IT WAS REPORTED THAT PRIOR TO USE OF A MC3 NAUTILUS VITALFLOW (VF) EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR,THE INLET PRESSURES WERE NOT REGISTERING . THE ISSUE WAS ADDRESSED BY UNPLUGGING THE NAUTILUS AND PLUGGING IT BACK IN, AFTER WHICH IT WAS CORRECTED AND WORKED PROPERLY. THE USE OF THE DEVICE WAS CONTINUED TO COMPLETE THE CASE.THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21099607 ↗
Other Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure devices
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- Novalung System Novalung consoleXenios AG · Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure7 deaths66 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.