CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMag RVAD HDE KIT, REF: 104318; CentriMag Pre-connected Pack, REF: CMAEK00; CentriMag VAD KIT, REF: 201-51006, 201-51007, 201-90001 201-90001T; Blood Pump with CentriMag Acute Circulatory Support System for ECMO, REF: CMAEK01. CentriMag Blood Pump is a component to be used with CentriMag Acute Circulatory Support System

Acute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the screw-in locking feature. Failure to properly lock the pump into motor my not cause pump not inserted alarm, and could lead to particulate, increased heat, anxiety, inconvenience, delay in hemodynamic/ECMO support, stroke, embolism, death.

In December 2024 Abbott sent a Product Information Letter to reinforce existing IFU. On 10/10/2025, correction notices were delivered by sales representatives to customers who were asked to do the following: Ensure the blood pump is securely locked into the motor, following the IFU. If you are unable to fully rotate and lock a blood pump into a motor, exchange the pump for a new one, and return the original pump to Abbott for a full refund or credit, please contact your Abbott Representative or Abbott Customer Service at 1-800-456-1477. Continue to follow the IFU, which can be accessed on firm website: https://manuals.eifu.abbott/en/index.html, and also follow the Pump Setup, Appendix A, in this notice, which states: The following pictures on Figure 1 clarify the IFU. After matching the grooves on the periphery of the Pump with the fittings on the motor receptacle, proceed with the following: 1. Ensuring that the pump remains flat/level with the motor/ to the pump, Rotate the pump counterclockwise until the matching groove on the pump is located in front of the locking screw. 2. Turn the locking screw until it is completely seated into the groove and the blood pump is secured in place. 3. Do not lock screw if groove is not located in front of the locking screw. 4. Always rely on visual confirmation that the pump is correctly locked in the motor, even if the "pump not inserted" alarm is not present. Communicate this information with those in your facility to whom it is relevant. Firm asks customers to notify all involved parties that support patients with affected devices. Complete and return the Acknowledgment and Receipt Form via email to [email protected] Firm has implemented an in-process manufacturing step to confirm the pumps can be fitted into the motor while continuing with the implementation of corrective actions to help ensure that new blood pumps will lock into the motor.