Z-1309-2024Class II

NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to...

Name: Z-1309-2024 NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to...
Creator: Mc3 Inc
Published: 2023-10-11
License: https://open.fda.gov/license/

MC3, Inc. / initiated 2023-10-11 / Open, Classified / root cause: manufacturing process

FDA source

Mc3 Inc began a recall of NautilusTM ECMO Oxygenator with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood... on 2023-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1309-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-10-11
Posted: 2024-03-19
Recalling firm: MC3, Inc.
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
Product code: BYS Oxygenator, Long Term Support Greater Than 6 Hours
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Medtronic (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 [email protected] " 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 commerce: 299 units
Distribution: US Nationwide distribution.
Product codes and lots: GTIN: (1) 10854916006888; (2) 10854916006901,20854916006908 (New GTIN (USA only)After reboxing). All Serial Numbers between 481022923 and 481024039

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1309-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1309-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19
Z-1310-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-27	2024-03-19

Product code BYS

K191935Class IINautilus Smart ECMO ModuleMc3 Incorporated / cleared 2020-04-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)