Recall Z-1310-2024 ยท BYS Oxygenator, Long Term Support Greater Than 6 Hours
Mc3 Inc
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
| Date | Mar 19, 2024 (initiated Oct 11, 2023) |
| Status | Open, Classified |
| Reason | 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 | 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 |
| Quantity | 188 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K191935 | Nautilus Smart ECMO Module Mc3 Incorporated, Apr 9, 2020 |