Nautilus ECMO Oxygenator recalled due to heat exchanger water path restriction
Mc3 Inc recalls Nautilus ECMO Oxygenator units due to heat exchanger water path restriction that degrades temperature control performance. Inadequate heat transfer may lead to hypothermia risk.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with serious potential harm (hypothermia in life-support patients) but no reported illnesses or injuries. Qualifies as risk-of-harm product without reported injury, scoring High per rubric criteria.
Plain-English summary
Mc3 Inc is recalling 299 units of the Nautilus ECMO Oxygenator with Balance Biosurface, a medical device used in extracorporeal life support (ECMO) procedures to oxygenate blood, remove carbon dioxide, and regulate blood temperature. The recalled units (Serial Numbers 481022923 to 481024039, distributed nationwide) may have increased water path restriction within the heat exchanger.
This water path restriction can degrade heat exchange performance. Water flow may be reduced immediately upon priming or may worsen during the procedure. According to the device's instructions for use, potential harm includes hypothermia due to inadequate heat transfer, which is particularly dangerous in patients dependent on extracorporeal life support.
The recalled product
- Product
- 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
- Manufacturer
- Mc3 Inc
- Affected units
- 299
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GTIN: (1) 10854916006888
- (2) 10854916006901
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Mc3 Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Mc3 Inc
See all →- HighECMO heat exchanger module recalled due to water path restriction
FDA (Devices) · 2024-03-27
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