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U.S. Department of Health and Human Services

Class 2 Device Recall Nautilus Smart ECMO Module with Balance Biosurface

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 Class 2 Device Recall Nautilus Smart ECMO Module with Balance Biosurfacesee related information
Date Initiated by FirmOctober 11, 2023
Date PostedMarch 19, 2024
Recall Status1 Open3, Classified
Recall NumberZ-1310-2024
Recall Event ID 94016
510(K)NumberK191935 
Product Classification Oxygenator, long term support greater than 6 hours - Product Code BYS
ProductNautilusTM 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
Code Information GTIN:(1)10854916006871; (2)10854916006895 All Serial Numbers between 481022923 and 481024039
Recalling Firm/
Manufacturer		 Mc3 Inc
2555 Bishop Cir W
Dexter MI 48130-1563
Manufacturer 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
FDA Determined
Cause 2		Process control
ActionMedtronic (MC3's global distributor)issued issued Urgent Customer Notification letter to end-users on 11/26/24. Letter states reason for recall, health risk and action to take: " During the priming procedure, users may check water flow through the oxygenator water path prior to use. " Patient core body temperature must be monitored routinely during ECMO. Customer Actions: Medtronic records indicate that your facility has received at least one of the impacted serial numbers. As a result, Medtronic requests that you take the following actions: " Complete the enclosed Customer Confirmation Form, acknowledging that you have received this information, and email to rs.cfqfca@medtronic.com " This notice must be passed on to all who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. We regret any inconvenience this may cause. We are committed to patient safety and appreciate your prompt attention to this matter. If you have any questions regarding this communication, please contact your Medtronic Field Representative
Quantity in Commerce188 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = BYS
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