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
This recall is currently active, issued March 19, 2024.
- Recall Initiated
- October 11, 2023
- Posted
- March 19, 2024
- Recall Number
- Z-1310-2024
- Quantity
- 188 units
- Firm Location
- Dexter, MI
- Official Source
- View on FDA website ↗
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
Distribution
US Nationwide distribution.
Lot / Code Info
GTIN:(1)10854916006871; (2)10854916006895 All Serial Numbers between 481022923 and 481024039
Root Cause
Process control
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