MC3 Nautilus ECMO Oxygenator 48145ERecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10854916006901), received between Dec 9, 2021 and Dec 10, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Oct 11, 2023Class IIOpen, Classified

   May have increased water path restriction within the heat exchanger, leading to degraded heat exchange performance during use. The reduction of water flow and reduced heat exchange performance may be experienced immediately upon priming or may worsen over the duration of use. The potential harm as stated in the IFU includes hypothermia due to inadequate heat transfer

   Z-1309-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT PRIOR TO USE OF THE MC3 NAUTILUS EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR, AFTER PRIMING AND CONNECTION TO THE PATIENT, BLOOD CAME OUT FROM THE GAS OUTLET. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20890337 ↗
• MalfunctionJan 18, 2024Infusion or Flow Problem; Infusion or Flow Problem

  ON (B)(6) 2023, WITHIN 10 MINUTES OF ECMO BYPASS, THE DELTA P WAS GREATER THAN 380 MMHG. DONOR BLOOD WAS GIVEN TO THE PATIENT AT THE INITIATION OF ECMO AND THE PATIENT WAS NOT SEPTIC. THERE WAS NO LOW GAS EXCHANGE OBSERVED. HEPARIN WAS GIVEN, ACT WAS REPORTED IN THE 200'S. IT WAS UNKNOWN IF THE PATIENT HAD PREVIOUSLY BEEN ON ANTI-COAGULATION THERAPY. THE NAUTILUS OXYGENATOR WAS REPLACED WITH NO IMPACT TO THE PATIENT. IT WAS REPORTED THAT A CLOT WAS OBSERVED IN THE OXYGENATOR AFTER THE DEVICE HAD BEEN REPLACED. THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18539860 ↗
• MalfunctionJan 12, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ON (B)(6) 2023, AFTER LESS THAN 24 HOURS USE OF A NAUTILUS OXYGENATOR, THE OUTLET HAD A LEAK AND WAS DRIPPING. THE OXYGENATOR WAS REPLACED WITH NO IMPACT TO THE PATIENT. THE PATIENT WAS REPORTED AS ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18503752 ↗
• MalfunctionDec 9, 2021Fluid/Blood Leak; Fluid/Blood Leak

  FLUID LEAK OUT OF GAS OUTLET PORT. DEVICE CHANGED OUT AND REPLACED WITH ANOTHER NAUTILUS OXYGENATOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12969663 ↗