NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures...
FDA Device Recall #Z-1309-2024 — Class II — October 11, 2023
Recall Summary
| Recall Number | Z-1309-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 11, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mc3 Inc |
| Location | Dexter, MI |
| Product Type | Devices |
| Quantity | 299 units |
Product Description
NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: (1) 48145; (2) 48145E
Reason for Recall
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
Distribution Pattern
US Nationwide distribution.
Lot / Code Information
GTIN: (1) 10854916006888; (2) 10854916006901,20854916006908 (New GTIN (USA only)After reboxing). All Serial Numbers between 481022923 and 481024039
Other Recalls from Mc3 Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1310-2024 | Class II | NautilusTM Smart ECMO Module with Balance Biosu... | Oct 11, 2023 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.