MC3 Nautilus Smart ECMO Module 48135ERecalls & reported problems

Michigan Critical Care Consultants, Inc. · Nautilus ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures 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. Smart ECMO Module device contains integrated sensors with an electronic touch screen display. The following measured parameters are visible on the electronic display: inlet pressure, inlet oxygen saturation, outlet pressure, outlet oxygen saturation, and outlet blood temperature. · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10854916006895), received between Oct 20, 2025 and Oct 20, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Air/Gas in Device” (1 report).

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 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Recalls naming this device

Oct 11, 2023Open, 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-1310-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Device problems

Air/Gas in Device1
Increase in Pressure1
Obstruction of Flow1

Patient problems

No Clinical Signs, Symptoms or Conditions1
Thrombocytopenia1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

MalfunctionOct 20, 2025Increase in Pressure; Obstruction of Flow; Air/Gas in Device; Increase in Pressure; Obstruction of Flow; Air/Gas in Device
IT WAS REPORTED THAT AN ALLEGED PRODUCT ISSUE OCCURRED WITH THE MC3 NAUTILUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) OXYGENATOR DURING USE. THE CIRCUIT WITH THE DEVICE WAS INITIALLY PRIMED AND LEFT READY FOR USE. AFTER SEVERAL DAYS, A PATIENT WAS CANNULATED AND CONNECTED TO THE CIRCUIT. JUST BEFORE CONNECTING THE PATIENT, AIR AND BUBBLES WERE OBSERVED IN THE SUPERIOR PART OF THE DEVICE, PROMPTING THE TEAM TO ATTEMPT RE-PRIMING USING A STERILE SYRINGE AND SERUM THROUGH THE CONNECTION INSIDE, COLLECTING IT THROUGH THE OUTSIDE CONNECTION. ONCE RE-PRIMED, THE PATIENT WAS CONNECTED TO THE CIRCUIT. DURING ECMO, A BLANK TOP WAS OBSERVED ON THE IN SIDE OF THE NAUTILUS SMART, APPEARING AS IF THERE WAS AIR AND NO BLOOD, WHILE THE OUT SIDE DID NOT SHOW THIS FEATURE. IT WAS NOTED THAT THE PATIENT WAS NOT COAGULATED. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Thrombocytopenia
MAUDE report 23334261 ↗

Device details

UDI-DI	`10854916006895`
Brand	MC3 Nautilus Smart ECMO Module
Model	48135E
Company	Michigan Critical Care Consultants, Inc.
Product code	BYS · Oxygenator, Long Term Support Greater Than 6 Hours
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Aug 23, 2024

Device type (GMDN): Extracorporeal membrane oxygenator

A device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. This is a single-use device.

Other Oxygenator, Long Term Support Greater Than 6 Hours devices

MC3 Nautilus(tm) ECMO Oxygenator 48145
Michigan Critical Care Consultants, Inc. · Oxygenator, Long Term Support Greater Than 6 Hours
1 recall3 deaths47 reports
MC3 Nautilus (tm) Smart ECMO Module 48135
Michigan Critical Care Consultants, Inc. · Oxygenator, Long Term Support Greater Than 6 Hours
1 recall27 reports
MC3 Nautilus ECMO Oxygenator 48145E
Michigan Critical Care Consultants, Inc. · Oxygenator, Long Term Support Greater Than 6 Hours
1 recall4 reports

All Oxygenator, Long Term Support Greater Than 6 Hours devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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