Mc3 Inc: Nautilus ECMO Oxygenator and Modules Recalled for Heat Exchange Failure

Agency Publication Date: March 19, 2024

Summary

Mc3 Inc is recalling 487 units of the NautilusTM ECMO Oxygenator and Smart ECMO Module used in life support procedures to regulate blood temperature and oxygen. These devices may have a restriction in the water path of the heat exchanger, which can significantly degrade its ability to warm or cool a patient's blood. The defect may be apparent immediately during priming or develop over the course of treatment. Consumers should contact their healthcare provider or the manufacturer, Mc3 Inc, for further instructions regarding these affected units.

Risk

The restricted water flow reduces the efficiency of the heat exchanger, which can lead to inadequate heat transfer and cause life-threatening hypothermia in patients undergoing extracorporeal life support.

What You Should Do

Identify if your device is affected by checking the product number and serial number on the packaging or device label. Affected products include NautilusTM ECMO Oxygenator (Product Numbers 48145, 48145E) and NautilusTM Smart ECMO Module (Product Numbers 48135, 48135E).
Verify the Serial Number against the affected range: All serial numbers between 481022923 and 481024039 are included in this recall.
Check for specific GTIN identifiers: For Oxygenators, check for 10854916006888, 10854916006901, or 20854916006908. For Smart ECMO Modules, check for 10854916006871 or 10854916006895.
Contact Mc3 Inc at their Dexter, Michigan facility or your healthcare provider immediately for further instructions and to coordinate potential replacement or management of the devices.
Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions regarding this medical device recall.

Your Remedy Options

Other Action

Contact healthcare provider or manufacturer

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: NautilusTM ECMO Oxygenator with Balance Biosurface

Model / REF:

48145

48145E

UPC Codes:

10854916006888

10854916006901

20854916006908

Lot Numbers:

Serial Numbers 481022923 through 481024039

Product: NautilusTM Smart ECMO Module with Balance Biosurface

Model / REF:

48135

48135E

UPC Codes:

10854916006871

10854916006895

Lot Numbers:

Serial Numbers 481022923 through 481024039

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94016

Status: Active

Manufacturer: Mc3 Inc

Sold By: Mc3 Inc

Manufactured In: United States

Units Affected: 2 products (299 units; 188 units)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Identify if your device is affected by checking the product number and serial number on the packaging or device label. Affected products include NautilusTM ECMO Oxygenator (Product Numbers 48145, 48145E) and NautilusTM Smart ECMO Module (Product Numbers 48135, 48135E).

Verify the Serial Number against the affected range: All serial numbers between 481022923 and 481024039 are included in this recall.

Check for specific GTIN identifiers: For Oxygenators, check for 10854916006888, 10854916006901, or 20854916006908. For Smart ECMO Modules, check for 10854916006871 or 10854916006895.

Contact Mc3 Inc at their Dexter, Michigan facility or your healthcare provider immediately for further instructions and to coordinate potential replacement or management of the devices.

Contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls if you have additional questions regarding this medical device recall.

Affected Products

Product: NautilusTM ECMO Oxygenator with Balance Biosurface

Model / REF:

48145

48145E

UPC Codes:

10854916006888

10854916006901

20854916006908

Lot Numbers:

Serial Numbers 481022923 through 481024039

Product: NautilusTM Smart ECMO Module with Balance Biosurface

Model / REF:

48135

48135E

UPC Codes:

10854916006871

10854916006895

Lot Numbers:

Serial Numbers 481022923 through 481024039