NautilusTM Smart ECMO Module with Balance Biosurface-used in extracorporeal life support procedures to oxygenate blood,

FDA device recall Z-1310-2024 · posted 2024-03-19 · Open, Classified

Recall details

Recalling firm

Mc3 Inc

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

Action taken

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 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

Root cause

Process control

Status

Open, Classified

Product code

BYS

Quantity affected

188 units

Distribution

US Nationwide distribution.

Date initiated

2023-10-11

Date posted

2024-03-19

Location

Dexter, MI

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