ECMO heat exchanger module recalled due to water path restriction
Mc3 Inc is recalling 188 Nautilus Smart ECMO modules nationwide due to potential water path restrictions in the heat exchanger that may cause inadequate heat transfer and risk of hypothermia during use.
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 recall with potential serious hazard (hypothermia from heat exchanger malfunction), but no reported illnesses or injuries. Per rubric, theoretical hazards without reported harm score at most 3 (High).
Plain-English summary
Mc3 Inc is recalling 188 units of the Nautilus Smart ECMO Module with Balance Biosurface due to a potential defect in the heat exchanger component.
The recalled devices may have increased water path restriction within the heat exchanger, which can lead to degraded heat exchange performance. This reduction in water flow and heat exchange effectiveness may occur immediately upon priming the device or worsen over the duration of use. According to the manufacturer's instructions for use, inadequate heat transfer can result in hypothermia.
These modules were distributed nationwide. The affected serial numbers are 481022923 through 481024039.
If you are operating an affected Nautilus Smart ECMO Module, contact Mc3 Inc immediately for guidance on replacement or mitigation measures.
The recalled product
- Product
- NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Product Number: 48135, 48135E
- Manufacturer
- Mc3 Inc
- Affected units
- 188
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)10854916006871
- (2)10854916006895 All Serial Numbers between 481022923 and 481024039
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 →- HighNautilus ECMO Oxygenator recalled due to heat exchanger water path restriction
FDA (Devices) · 2024-03-27
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